Edentulous MouthSMISNCT04760457

Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols

A study testing Implant placement with flapped surgery, Implant placement with flapless surgery and Implant immediate loading in people with Edentulous Mouth and Complete Edentulism, run by Universidade Federal de Goias at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention. The main study hypotheses are: 1. Read more about this study

Who is it for?: Any age
Conditions the study is for: Edentulous Mouth, Complete Edentulism
What is being tested?: Implant placement with flapped surgery, Implant placement with flapless surgery and Implant immediate loading
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteBrazil
Study dates: 1 Mar 2021to 30 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

No contraindications for implant surgery (mainly related to uncontrolled systemic diseases);
Enough bone height in the interforaminal area for an implant length of at least 10 mm;
Ability to understand and answer the questionnaires used in the study and agree to participate by providing a written informed consent.

Who cannot join

Noncompliant participants;
Disagreement to be randomly allocated to the treatment study groups;
Signs of untreated temporomandibular disorders or uncontrolled systemic or oral conditions that require additional treatments.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

School of Dentistry, Federal University of Goias
Goiânia, Goiás, 74605-220

Other trials in Brazil

About this study

Official title: One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures: a Factorial, Randomized Clinical Trial Testing the Outcomes of Immediate/Delayed Loading and Flapped/Flapless Surgery

The main study hypotheses are:

There are significant improvements in PROMs following implant intervention compared to baseline measures;
Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol.
Flapless surgery has similar post-insertion outcomes compared to flapped surgery.

Read the detailed description

Main study hypotheses:

There are significant improvements in PROMs following implant intervention compared to baseline measures;
Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol;
Flapless surgery has similar post-insertion outcomes compared to flapped surgery.

Statement of clinical relevance:

Mini implants are an alternative to standard implants for overdentures. They are suitable for insertion in narrow ridges, are less invasive, simpler, less costly, and faster to perform, and are especially advantageous for older and frail patients who would benefit from more conservative and less burdensome treatments. Although previous studies reported favorable outcomes regarding patient oral comfort and function, there is a need for implant/attachment systems with higher predictability on implant survival and retention performance in the long-term. This study aims to provide clinical evidence on the newly developed 2.4mm one-piece TiZr mini implant with a miniaturized carbon-based coating attachment.

Methods:

This is a randomized clinical trial using a factorial design, to test the effectiveness of a mandibular overdenture retained by four mini implants. Participants will be randomized using a 2×2 factorial design: immediate/delayed loading (factor 1) and flapless/flapped surgery (factor 2). New conventional complete dentures will be provided as the baseline treatment. Next, eligible participants will be those who completed a 6-month period of denture usage, and are in need of implants to improve the function of the mandibular denture. Imaging exam should present a minimum of 5.4 mm of ridge width in the interforaminal region (recommended for flapless surgery).

Included subjects to take part in the RCT will be randomized to the treatment groups according to the combined study factors - loading protocols: immediate (IL) or delayed (DL); and surgical approaches: flapless (FLS) or flapped (FPS) surgery. Hence, the combined factors will results in four groups:

IL/FLS (Group I)
IL/FPS (Group II)
DL/FLS (Group III)
DL/FPS (Group IV) Considering the patient's perspective this study design assumed a "worst" protocol (delayed and flapped - Group IV) and a "best" protocol (flapless and immediate - Group I) and two other intermediary conditions (flapped/immediate and flapless/delayed).

All participants will receive four Straumann® Mini Implant System (one-piece Tissue Level implants) with an Optiloc® prosthetic connection and PEEK matrix inserts. Surgery will follow the workflow for the surgical procedure for the Straumann® Mini Implant System concerning preoperative planning, implant bed preparation and implant insertion. For the prosthetic procedures, we will perform a chairside incorporation of the retentive inserts to convert the existing well-fitting and well-functioning lower denture into an overdenture with the Optiloc® Retentive System/Straumann® Mini Implants.

Outcomes will include short-term outcomes (Patient perceived burdens in surgery, postoperative swelling and pain, consumption of analgesics and surgical time) and long-term - 1-year (implant survival and success, peri-implant marginal bone level changes, PROMs, retention force, prosthodontic events) outcomes. Sample size calculation resulted in a total of 74 participants, 18 in each of the four groups. Data analysis will include descriptive and bivariate analyses, Kaplan-Meier curves and regression models using Generalized Estimating Equations (GEE) for longitudinal data.

Conditions: Edentulous Mouth, Complete Edentulism
Being tested: Implant placement with flapped surgery, Implant placement with flapless surgery, Implant immediate loading, Implant delayed loading
Keywords: Overdenture, Mini implant, Flapless surgery, Dental implant, Implant loading protocol
Medical subject headings: Mouth, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implant placement with flapped surgeryProcedure or surgery
Four mini implants will be placed reflecting a flap.
Implant placement with flapless surgeryProcedure or surgery
Four mini implants will be placed without reflecting a flap.
Implant immediate loadingProcedure or surgery
Four mini implants will be immediately loaded.
Implant delayed loadingProcedure or surgery
Four mini implants will be loaded after a 6-week healing period.

Study groups in NCT04760457
Study group	Role	What they receive
IL-FLS	Active comparator	Immediate loading (IL) and Flapless surgery (FLS) Receives: Procedure: Implant placement with flapless surgery; Procedure: Implant immediate loading
IL-FPS	Active comparator	Immediate loading (IL) and Flapped surgery (FPS) Receives: Procedure: Implant placement with flapped surgery; Procedure: Implant immediate loading
DL-FLS	Active comparator	Delayed loading (DL) and Flapless surgery (FLS) Receives: Procedure: Implant placement with flapless surgery; Procedure: Implant delayed loading
DL-FPS	Active comparator	Delayed loading (DL) and Flapped surgery (FPS) Receives: Procedure: Implant placement with flapped surgery; Procedure: Implant delayed loading

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-perceived burdens
The Burdens in Oral Surgery Questionnaire (BiOS-Q) will be used to assess patient-perceived burdens. It includes 16 items concerning all aspects of procedures occurring during a surgery. Responses for each item are assessed using a visual analogue scale (VAS) ranging from 0 = no expression of the attribute (e.g. not unpleasant at all) to 100 = maximum expression (e.g. very unpleasant).
Measured: Twenty-four hours after implant surgery.
Implant survival and success
Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.
Measured: Incidence thoughout the 12-month follow-up after implant placement.
Postoperative pain and discomfort
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Measured: Assessed 24 hours after implant placement.
Postoperative pain and discomfort
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Measured: Assessed 72 hours after implant placement.
Postoperative pain and discomfort
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Measured: Assessed 1 week after implant placement.
Consumption of analgesics
The number of analgesics consumed by the participant during the post-operative and healing period will be recorded in the patient's file.
Measured: Assessed until 1 week after implant placement.
Patient Satisfaction
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Measured: Assessed at baseline (before implant surgery)
Patient Satisfaction
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Measured: Assessed at the 3-month follow-up visit after implant placement.
Patient Satisfaction
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Measured: Assessed at the 6-month follow-up visit after implant placement.
Patient Satisfaction
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Measured: Assessed at the 12-month follow-up visit after implant placement.
Oral health-related quality of life (OHRQoL)
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Measured: Assessed at baseline (before implant surgery).
Oral health-related quality of life (OHRQoL)
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Measured: Assessed at the 3-month follow-up visit after implant placement.
Oral health-related quality of life (OHRQoL)
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Measured: Assessed at the 6-month follow-up visit after implant placement.
Oral health-related quality of life (OHRQoL)
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Measured: Assessed at the 12-month follow-up visit after implant placement.
Prosthodontic maintenance events
The incidence of prosthodontic repair/adjustment events will be recorded during the clinical assessments.
Measured: Throughout 12 months after overdenture delivery.
Surgical time
The time interval concerning the clinical visit for implant placement and delivery of the overdenture or denture adaptation will me measured and registered.
Measured: Procedure (Assessed during the clinical visit of implant placement and overdenture delivery or denture adaptation.)

Secondary outcomes (17)

Masticatory Performance
To perform the masticatory performance test two gums in a dragée form will be used, one blue and one pink, which need to be stuck together manually by wetting them with water and applying moderate force. The participants will be instructed to chew 2 samples of the gum on theirs preferred chewing side for 20 and 50 chewing cycles, respectively, leaving an interval of 1 minute between each chewing sequence.
Measured: Assessed at baseline (before implant surgery).
Masticatory Performance
To perform the masticatory performance test two gums in a dragée form will be used, one blue and one pink, which need to be stuck together manually by wetting them with water and applying moderate force. The participants will be instructed to chew 2 samples of the gum on theirs preferred chewing side for 20 and 50 chewing cycles, respectively, leaving an interval of 1 minute between each chewing sequence.
Measured: Assessed at the 3-month follow-up visit after implant placement.
Masticatory Performance
To perform the masticatory performance test two gums in a dragée form will be used, one blue and one pink, which need to be stuck together manually by wetting them with water and applying moderate force. The participants will be instructed to chew 2 samples of the gum on theirs preferred chewing side for 20 and 50 chewing cycles, respectively, leaving an interval of 1 minute between each chewing sequence.
Measured: Assessed at the 6-month follow-up visit after implant placement.
Masticatory Performance
To perform the masticatory performance test two gums in a dragée form will be used, one blue and one pink, which need to be stuck together manually by wetting them with water and applying moderate force. The participants will be instructed to chew 2 samples of the gum on theirs preferred chewing side for 20 and 50 chewing cycles, respectively, leaving an interval of 1 minute between each chewing sequence.
Measured: Assessed at the 12-month follow-up visit after implant placement.
Maximum voluntary bite force
Maximum voluntary bite force will be measured with a digital gauge (IDDK - Kratos, Cotia, São Paulo, Brazil) in the region of the first molar with three assessments per side.
Measured: Assessed at baseline (before implant surgery).
Maximum voluntary bite force
Maximum voluntary bite force will be measured with a digital gauge (IDDK - Kratos, Cotia, São Paulo, Brazil) in the region of the first molar with three assessments per side.
Measured: Assessed at the 3-month follow-up visit after implant placement.
Maximum voluntary bite force
Maximum voluntary bite force will be measured with a digital gauge (IDDK - Kratos, Cotia, São Paulo, Brazil) in the region of the first molar with three assessments per side.
Measured: Assessed at the 6-month follow-up visit after implant placement.
Maximum voluntary bite force
Maximum voluntary bite force will be measured with a digital gauge (IDDK - Kratos, Cotia, São Paulo, Brazil) in the region of the first molar with three assessments per side.
Measured: Assessed at the 12-month follow-up visit after implant placement.
Peri-implant bone change
Periapical radiographs will be obtained and the peri-implant bone level will be measured and compared longitudinally.
Measured: Peri-implant bone loss at the 3-month follow-up compared to initial stage (1-week rediograph).
Peri-implant bone change
Periapical radiographs will be obtained and the peri-implant bone level will be measured and compared longitudinally.
Measured: Peri-implant bone loss at the 6-month follow-up compared to initial stage (1-week rediograph).
Peri-implant bone change
Periapical radiographs will be obtained and the peri-implant bone level will be measured and compared longitudinally.
Measured: Peri-implant bone loss at the 12-month follow-up compared to initial stage (1-week rediograph).
Bleeding on probing
Incidence of inflammation of the peri-implant soft tissues
Measured: Assessed at 6-month post-insertion
Bleeding on probing
Incidence of inflammation of the peri-implant soft tissues
Measured: Assessed at 12-month post-insertion
Probing depth
Level of the peri-implant sulcus (in milimiters)
Measured: Assessed at 6-month post-insertion
Probing depth
Level of the peri-implant sulcus (in milimiters)
Measured: Assessed at 12-month post-insertion
Suppuration
Incidence of suppuration on probing the peri-implant soft tissues
Measured: Assessed at 6-month post-insertion
Suppuration
Incidence of suppuration on probing the peri-implant soft tissues
Measured: Assessed at 12-month post-insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Nov 2022

First posted18 Feb 2021
Study start1 Mar 2021
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Edentulous MouthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: A factorial experiment of two factors is planned, each with two possible values or "levels", and whose experimental units take on all possible combinations of these levels across all such factors (2×2 factorial design), allowing the study to determine the effect of each factor on the response variable, as well as the effects of interactions between factors on the response variable. The tested factors will be: loading protocol (immediate or delayed), and surgical approach (flapped or flapless), resulting in a factorial experiment with four treatment combinations in total. Hence, the design is denoted a 2² factorial, which identifies the number of factors (n=2) and how many levels each factor has (n=2) there are in the design (2²=4).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04760457
Sponsor's protocol ID: PI04011-2019
Acronym: SMIS
Status last verified: May 2023
First submitted: 27 Jan 2021
Last updated: 10 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Clinical data will be implemented electronically using a dedicated electronic data capturing (EDC) system (REDCap DMS, https://www.project-redcap.org/), hosted by the server infrastructure of the Federal University of Goias. Data will be entered in REDCap using either the web-based application or the REDCap mobile app for iOS/Android. Baseline and longitudinal health-related data, and patient identifying codes used for the analysis will be entered in a REDCap database. The Report Builder will be used to create customized reports that are queried in real time.

Publications

Awad MA, Feine JS. Measuring patient satisfaction with mandibular prostheses. Community Dent Oral Epidemiol. 1998 Dec;26(6):400-5. doi: 10.1111/j.1600-0528.1998.tb01978.x.
PubMed 9870539
de Grandmont P, Feine JS, Tache R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. J Dent Res. 1994 May;73(5):1096-104. doi: 10.1177/00220345940730051201.
PubMed 8006237
Demain S, Goncalves AC, Areia C, Oliveira R, Marcos AJ, Marques A, Parmar R, Hunt K. Living with, managing and minimising treatment burden in long term conditions: a systematic review of qualitative research. PLoS One. 2015 May 29;10(5):e0125457. doi: 10.1371/journal.pone.0125457. eCollection 2015.
PubMed 26024379
Enkling N, Saftig M, Worni A, Mericske-Stern R, Schimmel M. Chewing efficiency, bite force and oral health-related quality of life with narrow diameter implants - a prospective clinical study: results after one year. Clin Oral Implants Res. 2017 Apr;28(4):476-482. doi: 10.1111/clr.12822. Epub 2016 Mar 24.
PubMed 27009835
Enkling N, Haueter M, Worni A, Muller F, Leles CR, Schimmel M. A prospective cohort study on survival and success of one-piece mini-implants with associated changes in oral function: Five-year outcomes. Clin Oral Implants Res. 2019 Jun;30(6):570-577. doi: 10.1111/clr.13444. Epub 2019 May 8.
PubMed 31021481
Kanazawa M, Feine J, Esfandiari S. Clinical guidelines and procedures for provision of mandibular overdentures on 4 mini-dental implants. J Prosthet Dent. 2017 Jan;117(1):22-27. doi: 10.1016/j.prosdent.2016.04.020. Epub 2016 Aug 1.
PubMed 27492988
Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3.
PubMed 24660189
Leao A, Sheiham A. Relation between clinical dental status and subjective impacts on daily living. J Dent Res. 1995 Jul;74(7):1408-13. doi: 10.1177/00220345950740071301.
PubMed 7560392
Leao A, Sheiham A. The development of a socio-dental measure of dental impacts on daily living. Community Dent Health. 1996 Mar;13(1):22-6.
PubMed 8634892
Lemos CA, Verri FR, Batista VE, Junior JF, Mello CC, Pellizzer EP. Complete overdentures retained by mini implants: A systematic review. J Dent. 2017 Feb;57:4-13. doi: 10.1016/j.jdent.2016.11.009. Epub 2016 Nov 22.
PubMed 27888049
Marcello-Machado RM, Faot F, Schuster AJ, Nascimento GG, Del Bel Cury AA. Mini-implants and narrow diameter implants as mandibular overdenture retainers: A systematic review and meta-analysis of clinical and radiographic outcomes. J Oral Rehabil. 2018 Feb;45(2):161-183. doi: 10.1111/joor.12585. Epub 2017 Dec 2.
PubMed 29125652
Reissmann DR, Semmusch J, Farhan D, Smeets R, Heiland M, Heydecke G. Development and validation of the Burdens in Oral Surgery Questionnaire (BiOS-Q). J Oral Rehabil. 2013 Oct;40(10):780-7. doi: 10.1111/joor.12092. Epub 2013 Aug 27.
PubMed 24033878
Reissmann DR, Enkling N, Moazzin R, Haueter M, Worni A, Schimmel M. Long-term changes in oral health-related quality of life over a period of 5 years in patients treated with narrow diameter implants: A prospective clinical study. J Dent. 2018 Aug;75:84-90. doi: 10.1016/j.jdent.2018.05.019. Epub 2018 May 28.
PubMed 29852211
Schiegnitz E, Al-Nawas B. Narrow-diameter implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:21-40. doi: 10.1111/clr.13272.
PubMed 30328192
Souza RF, Patrocinio L, Pero AC, Marra J, Compagnoni MA. Reliability and validation of a Brazilian version of the Oral Health Impact Profile for assessing edentulous subjects. J Oral Rehabil. 2007 Nov;34(11):821-6. doi: 10.1111/j.1365-2842.2007.01749.x.
PubMed 17919248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures: a Factorial, Randomized Clinical Trial Testing the Outcomes of Immediate/Delayed Loading and Flapped/Flapless Surgery
ClinicalTrials.gov ID: NCT04760457
Acronym / sponsor ID: SMIS / PI04011-2019
Conditions: Edentulous Mouth, Complete Edentulism
Keywords: Overdenture, Mini implant, Flapless surgery, Dental implant, Implant loading protocol
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Universidade Federal de GoiasUniversity, hospital or other
Collaborators: ITI International Team for Implantology, Switzerland, Institut Straumann AG
Study start: 1 Mar 2021 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 18 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main study hypotheses are:

There are significant improvements in PROMs following implant intervention compared to baseline measures;
Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol.
Flapless surgery has similar post-insertion outcomes compared to flapped surgery.

Detailed description

Main study hypotheses:

There are significant improvements in PROMs following implant intervention compared to baseline measures;
Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol;
Flapless surgery has similar post-insertion outcomes compared to flapped surgery.

Statement of clinical relevance:

Methods:

IL/FLS (Group I)
IL/FPS (Group II)
DL/FLS (Group III)
DL/FPS (Group IV) Considering the patient's perspective this study design assumed a "worst" protocol (delayed and flapped - Group IV) and a "best" protocol (flapless and immediate - Group I) and two other intermediary conditions (flapped/immediate and flapless/delayed).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: A factorial experiment of two factors is planned, each with two possible values or "levels", and whose experimental units take on all possible combinations of these levels across all such factors (2×2 factorial design), allowing the study to determine the effect of each factor on the response variable, as well as the effects of interactions between factors on the response variable. The tested factors will be: loading protocol (immediate or delayed), and surgical approach (flapped or flapless), resulting in a factorial experiment with four treatment combinations in total. Hence, the design is denoted a 2² factorial, which identifies the number of factors (n=2) and how many levels each factor has (n=2) there are in the design (2²=4).

Arm	Type	Receives
IL-FLS	Active comparator	Procedure: Implant placement with flapless surgery, Procedure: Implant immediate loadingImmediate loading (IL) and Flapless surgery (FLS)
IL-FPS	Active comparator	Procedure: Implant placement with flapped surgery, Procedure: Implant immediate loadingImmediate loading (IL) and Flapped surgery (FPS)
DL-FLS	Active comparator	Procedure: Implant placement with flapless surgery, Procedure: Implant delayed loadingDelayed loading (DL) and Flapless surgery (FLS)
DL-FPS	Active comparator	Procedure: Implant placement with flapped surgery, Procedure: Implant delayed loadingDelayed loading (DL) and Flapped surgery (FPS)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

No contraindications for implant surgery (mainly related to uncontrolled systemic diseases);
Enough bone height in the interforaminal area for an implant length of at least 10 mm;
Ability to understand and answer the questionnaires used in the study and agree to participate by providing a written informed consent.

Key exclusion criteria (3 listed)

Noncompliant participants;
Disagreement to be randomly allocated to the treatment study groups;
Signs of untreated temporomandibular disorders or uncontrolled systemic or oral conditions that require additional treatments.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implant placement with flapped surgeryFour mini implants will be placed reflecting a flap.	Procedure or surgery	DL-FPS, IL-FPS
Implant placement with flapless surgeryFour mini implants will be placed without reflecting a flap.	Procedure or surgery	DL-FLS, IL-FLS
Implant immediate loadingFour mini implants will be immediately loaded.	Procedure or surgery	IL-FLS, IL-FPS
Implant delayed loadingFour mini implants will be loaded after a 6-week healing period.	Procedure or surgery	DL-FLS, DL-FPS

Primary outcome

Patient-perceived burdens
Time frame: Twenty-four hours after implant surgery.
The Burdens in Oral Surgery Questionnaire (BiOS-Q) will be used to assess patient-perceived burdens. It includes 16 items concerning all aspects of procedures occurring during a surgery. Responses for each item are assessed using a visual analogue scale (VAS) ranging from 0 = no expression of the attribute (e.g. not unpleasant at all) to 100 = maximum expression (e.g. very unpleasant).
Implant survival and success
Time frame: Incidence thoughout the 12-month follow-up after implant placement.
Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.
Postoperative pain and discomfort
Time frame: Assessed 24 hours after implant placement.
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Postoperative pain and discomfort
Time frame: Assessed 72 hours after implant placement.
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Postoperative pain and discomfort
Time frame: Assessed 1 week after implant placement.
A 100-cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along the scale.
Consumption of analgesics
Time frame: Assessed until 1 week after implant placement.
The number of analgesics consumed by the participant during the post-operative and healing period will be recorded in the patient's file.
Patient Satisfaction
Time frame: Assessed at baseline (before implant surgery)
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Patient Satisfaction
Time frame: Assessed at the 3-month follow-up visit after implant placement.
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Patient Satisfaction
Time frame: Assessed at the 6-month follow-up visit after implant placement.
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Patient Satisfaction
Time frame: Assessed at the 12-month follow-up visit after implant placement.
The McGill Denture Satisfaction Instrument - DSI (Awad \& Feine, 1998; de Grandmont et al., 1994) will be used to assess patients' satisfaction relating to their prostheses. This is a treatment-specific patient-based outcome assessing satisfaction relating to several aspects of the mandibular prosthesis, including general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?''. The subjects will answer on a 100 mm visual analogue scale (VAS) anchored by the words 'not at all satisfied' and 'extremely satisfied'.
Oral health-related quality of life (OHRQoL)
Time frame: Assessed at baseline (before implant surgery).
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Oral health-related quality of life (OHRQoL)
Time frame: Assessed at the 3-month follow-up visit after implant placement.
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Oral health-related quality of life (OHRQoL)
Time frame: Assessed at the 6-month follow-up visit after implant placement.
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Oral health-related quality of life (OHRQoL)
Time frame: Assessed at the 12-month follow-up visit after implant placement.
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Prosthodontic maintenance events
Time frame: Throughout 12 months after overdenture delivery.
The incidence of prosthodontic repair/adjustment events will be recorded during the clinical assessments.
Surgical time
Time frame: Procedure (Assessed during the clinical visit of implant placement and overdenture delivery or denture adaptation.)
The time interval concerning the clinical visit for implant placement and delivery of the overdenture or denture adaptation will me measured and registered.

17 secondary outcomes

Masticatory Performance
Time frame: Assessed at baseline (before implant surgery).
Masticatory Performance
Time frame: Assessed at the 3-month follow-up visit after implant placement.
Masticatory Performance
Time frame: Assessed at the 6-month follow-up visit after implant placement.
Masticatory Performance
Time frame: Assessed at the 12-month follow-up visit after implant placement.
Maximum voluntary bite force
Time frame: Assessed at baseline (before implant surgery).
Maximum voluntary bite force
Time frame: Assessed at the 3-month follow-up visit after implant placement.
Maximum voluntary bite force
Time frame: Assessed at the 6-month follow-up visit after implant placement.
Maximum voluntary bite force
Time frame: Assessed at the 12-month follow-up visit after implant placement.
Peri-implant bone change
Time frame: Peri-implant bone loss at the 3-month follow-up compared to initial stage (1-week rediograph).
Peri-implant bone change
Time frame: Peri-implant bone loss at the 6-month follow-up compared to initial stage (1-week rediograph).
Peri-implant bone change
Time frame: Peri-implant bone loss at the 12-month follow-up compared to initial stage (1-week rediograph).
Bleeding on probing
Time frame: Assessed at 6-month post-insertion
Bleeding on probing
Time frame: Assessed at 12-month post-insertion
Probing depth
Time frame: Assessed at 6-month post-insertion
Probing depth
Time frame: Assessed at 12-month post-insertion
Suppuration
Time frame: Assessed at 6-month post-insertion
Suppuration
Time frame: Assessed at 12-month post-insertion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Background: PubMed 9870539Awad MA, Feine JS. Measuring patient satisfaction with mandibular prostheses. Community Dent Oral Epidemiol. 1998 Dec;26(6):400-5. doi: 10.1111/j.1600-0528.1998.tb01978.x.
Background: PubMed 8006237de Grandmont P, Feine JS, Tache R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. J Dent Res. 1994 May;73(5):1096-104. doi: 10.1177/00220345940730051201.
Background: PubMed 26024379Demain S, Goncalves AC, Areia C, Oliveira R, Marcos AJ, Marques A, Parmar R, Hunt K. Living with, managing and minimising treatment burden in long term conditions: a systematic review of qualitative research. PLoS One. 2015 May 29;10(5):e0125457. doi: 10.1371/journal.pone.0125457. eCollection 2015.
Background: PubMed 27009835Enkling N, Saftig M, Worni A, Mericske-Stern R, Schimmel M. Chewing efficiency, bite force and oral health-related quality of life with narrow diameter implants - a prospective clinical study: results after one year. Clin Oral Implants Res. 2017 Apr;28(4):476-482. doi: 10.1111/clr.12822. Epub 2016 Mar 24.
Background: PubMed 31021481Enkling N, Haueter M, Worni A, Muller F, Leles CR, Schimmel M. A prospective cohort study on survival and success of one-piece mini-implants with associated changes in oral function: Five-year outcomes. Clin Oral Implants Res. 2019 Jun;30(6):570-577. doi: 10.1111/clr.13444. Epub 2019 May 8.
Background: PubMed 27492988Kanazawa M, Feine J, Esfandiari S. Clinical guidelines and procedures for provision of mandibular overdentures on 4 mini-dental implants. J Prosthet Dent. 2017 Jan;117(1):22-27. doi: 10.1016/j.prosdent.2016.04.020. Epub 2016 Aug 1.
Background: PubMed 24660189Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3.
Background: PubMed 7560392Leao A, Sheiham A. Relation between clinical dental status and subjective impacts on daily living. J Dent Res. 1995 Jul;74(7):1408-13. doi: 10.1177/00220345950740071301.
Background: PubMed 8634892Leao A, Sheiham A. The development of a socio-dental measure of dental impacts on daily living. Community Dent Health. 1996 Mar;13(1):22-6.
Background: PubMed 27888049Lemos CA, Verri FR, Batista VE, Junior JF, Mello CC, Pellizzer EP. Complete overdentures retained by mini implants: A systematic review. J Dent. 2017 Feb;57:4-13. doi: 10.1016/j.jdent.2016.11.009. Epub 2016 Nov 22.
Background: PubMed 29125652Marcello-Machado RM, Faot F, Schuster AJ, Nascimento GG, Del Bel Cury AA. Mini-implants and narrow diameter implants as mandibular overdenture retainers: A systematic review and meta-analysis of clinical and radiographic outcomes. J Oral Rehabil. 2018 Feb;45(2):161-183. doi: 10.1111/joor.12585. Epub 2017 Dec 2.
Background: PubMed 24033878Reissmann DR, Semmusch J, Farhan D, Smeets R, Heiland M, Heydecke G. Development and validation of the Burdens in Oral Surgery Questionnaire (BiOS-Q). J Oral Rehabil. 2013 Oct;40(10):780-7. doi: 10.1111/joor.12092. Epub 2013 Aug 27.
Individual participant dataSharing planned: Yes. Clinical data will be implemented electronically using a dedicated electronic data capturing (EDC) system (REDCap DMS, https://www.project-redcap.org/), hosted by the server infrastructure of the Federal University of Goias. Data will be entered in REDCap using either the web-based application or the REDCap mobile app for iOS/Android. Baseline and longitudinal health-related data, and patient identifying codes used for the analysis will be entered in a REDCap database. The Report Builder will be used to create customized reports that are queried in real time.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudio R Leles, DDS, PhD study director

Universidade Federal de Goias

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-perceived burdens (time frame: Twenty-four hours after implant surgery.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760457, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.