Dental ImplantsNCT05642520
Oval Abutment Versus a Circular Abutment in Dental Implants in the Anterior Maxillae
A study testing Oval section abutment of 2.9 mm and Circular section abutment of 3.3 mm in people with Dental Implants, run by Ana María García de la Fuente at 1 site in Spain.
Trial summary
Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Oval section abutment of 2.9 mm and Circular section abutment of 3.3 mm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 1 Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years of age
- Absence of upper lateral incisors or lower central / lateral incisors with an edentulous space of at least 6.4mm (mesio-distally).
- The teeth adjacent to the edentulous space must be natural.
- Patients who are in periodontal health.
- Signing of informed consent before entering the study.
Who cannot join
- Patients with any systemic condition or disease that may interfere with oral surgery.
- History of radiotherapy.
- Patients smoking more than 20 cigarettes per day.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial Comparing the Placement of an Oval Abutment in 2.9 mm Implants Versus a Circular Abutment in Implants of 3.3 mm to 12 Months of Evolution
Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors.
Material and methods: fourty patients received unitary implants of 3.3mm or 2.9 mm diameter to replace the absence of upper lateral incisor or lower central/lateral incisor with an edentulous space of at least 6.4mm (mesio-distally). Esthetic and clinical parameters were evaluated 12 months after installation of the prosthesis.
Read more
Condition or disease: dental implants
Intervention/treatment: 3.3 or 2.9 mm diameter dental implants
Phase: Not Applicable
Read the detailed description
The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth.
The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
The main objective was the papillary index (PI) (Jemt, 1997). It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
The secondary objectives are (a) to observe the stability of the soft and hard tissues after one year in function, (b) to assess the success and survival rate of the implants, (c) to assess the stability of the implants and their evolution and (d) to analyze the degree of patient satisfaction with the aesthetic result.
- Conditions
- Dental Implants
- Being tested
- Oval section abutment of 2.9 mm, Circular section abutment of 3.3 mm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oval section abutment of 2.9 mmProcedure or surgery
The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
Circular section abutment of 3.3 mmProcedure or surgery
Also called Prosthetic treatment over a circular section abutment of 3.3.mm
The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
| Study group | Role | What they receive |
|---|---|---|
| oval section abutment of a 2.9mm | Experimental | The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed.
Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). Receives: Procedure: Circular section abutment of 3.3 mm |
| circular section abutment in 3.3mm | Placebo comparator | The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). Receives: Procedure: Oval section abutment of 2.9 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective was the papillary index (PI) (Jemt, 1997)
It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
Measured: 12 months
Secondary outcomes (7)
To observe the stability of the soft and hard tissues after one year in function: probing depth
Probing depth (PD), defined as the distance (mm) between the most apical point of the gingival sulcus or periodontal pocket and the free gingival margin. It will be taken at six points per tooth and in four points by implant.
Measured: 12 months
To observe the stability of the soft and hard tissues after one year in function:bleeding on probing
Bleeding on probing (BP) (Ainamo and Bay 1975), presence of bleeding in six points per tooth (3 in vestibular and 3 in lingual or palatal).
Measured: 12 months
To observe the stability of the soft and hard tissues after one year in function: suppuration on probing
Suppuration on probing, presence of pus within 15 seconds after probing.
Measured: 12 months
To observe the stability of the soft and hard tissues after one year in function: Modified plaque index (MPI)
Modified plaque index (MPI) (Mombelli et al 1987): 0 = no plaque detected; 1 = detection of plaque when a periodontal probe passes over the surface of the implant; 2 = the plaque is visible to the naked eye; 3 = abundant plate.
Measured: 12 months
Assessment of survival rate of the implants
The survival rate of the implants will be recorded taking into consideration Albrektsson et al.´s criteria. (Albrektson et al 1986)
Measured: 12 months
Assessment of the success of the implants
The implant will be considered successful when: (a) non-detectable clinical mobility (manual test); (b) absence of radiolucency around the surface of the implant; (c) absence of persistent pain; (d) absence of recurrent peri-implant infection. (Buser et al. 1990)
Measured: 12 months
Analyze the degree of patient satisfaction with the aesthetic result.
Visual analog scale (VAS): the general patient satisfaction will be evaluated. The specific satisfaction with respect to 5 parameters will also be recorded - aesthetics, mastication, phonation, comfort and self-esteem - using 10 cm visual analog scales calibrated with the terms "nothing satisfied" and "totally satisfied" at the left and right ends respectively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Feb 2018
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth. The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana María García de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana María García de la Fuente, University of the Basque Country (UPV/EHU)
- Investigators
- ANA MARIA GARCIA DE LA FUENTE, PhD, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642520
- Sponsor's protocol ID
- 2018_01
- Status last verified
- Jul 2023
- First submitted
- 18 Nov 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will only be used for the purposes of this project.
Publications
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 24660189Patil RC, den Hartog L, van Heereveld C, Jagdale A, Dilbaghi A, Cune MS. Comparison of two different abutment designs on marginal bone loss and soft tissue development. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):675-81. doi: 10.11607/jomi.3363.
PubMed 24818207Froum SJ, Natour M, Cho SC, Yu PYC, Leung M. Expanded Clinical Applications of Narrow-Diameter Implants for Permanent Use. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):529-537. doi: 10.11607/prd.4565.
PubMed 32559035Roccuzzo A, Imber JC, Jensen SS. Need for lateral bone augmentation at two narrow-diameter implants: A prospective, controlled, clinical study. Clin Oral Implants Res. 2021 Apr;32(4):511-520. doi: 10.1111/clr.13721. Epub 2021 Mar 1.
PubMed 33548077Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
PubMed 3507627Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
PubMed 2099210Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955Herrera-Perez P, Garcia-De-La-Fuente AM, Andia-Larrea E, Marichalar-Mendia X, Aguirre-Urizar JM, Aguirre-Zorzano LA. Clinical analysis of the tooth-implant papilla for two narrow-diameter titanium-zirconium implants in the anterior area: prospective controlled clinical study. BMC Oral Health. 2024 Mar 5;24(1):310. doi: 10.1186/s12903-024-04075-2.
PubMed 38443879
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing the Placement of an Oval Abutment in 2.9 mm Implants Versus a Circular Abutment in Implants of 3.3 mm to 12 Months of Evolution
- ClinicalTrials.gov ID
- NCT05642520
- Acronym / sponsor ID
- 2018_01
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ana María García de la FuenteUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Dec 2022 (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.
Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors.
Material and methods: fourty patients received unitary implants of 3.3mm or 2.9 mm diameter to replace the absence of upper lateral incisor or lower central/lateral incisor with an edentulous space of at least 6.4mm (mesio-distally). Esthetic and clinical parameters were evaluated 12 months after installation of the prosthesis.
Condition or disease: dental implants
Intervention/treatment: 3.3 or 2.9 mm diameter dental implants
Phase: Not Applicable
Detailed description
The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth.
The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
The main objective was the papillary index (PI) (Jemt, 1997). It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
The secondary objectives are (a) to observe the stability of the soft and hard tissues after one year in function, (b) to assess the success and survival rate of the implants, (c) to assess the stability of the implants and their evolution and (d) to analyze the degree of patient satisfaction with the aesthetic result.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth. The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
| Arm | Type | Receives |
|---|---|---|
| oval section abutment of a 2.9mm | Experimental | Procedure: Circular section abutment of 3.3 mmThe choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). |
| circular section abutment in 3.3mm | Placebo comparator | Procedure: Oval section abutment of 2.9 mmThe choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >18 years of age
- Absence of upper lateral incisors or lower central / lateral incisors with an edentulous space of at least 6.4mm (mesio-distally).
- The teeth adjacent to the edentulous space must be natural.
- Patients who are in periodontal health.
- Signing of informed consent before entering the study.
Key exclusion criteria (4 listed)
- Patients with any systemic condition or disease that may interfere with oral surgery.
- History of radiotherapy.
- Patients smoking more than 20 cigarettes per day.
- Pregnant or breastfeeding patients.
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 |
|---|---|---|
| Oval section abutment of 2.9 mmThe choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). | Procedure or surgery | circular section abutment in 3.3mm |
| Circular section abutment of 3.3 mmAlso: Prosthetic treatment over a circular section abutment of 3.3.mmThe choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland). | Procedure or surgery | oval section abutment of a 2.9mm |
Primary outcome
The main objective was the papillary index (PI) (Jemt, 1997)
Time frame: 12 months
It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
7 secondary outcomes
To observe the stability of the soft and hard tissues after one year in function: probing depth
Time frame: 12 months
To observe the stability of the soft and hard tissues after one year in function:bleeding on probing
Time frame: 12 months
To observe the stability of the soft and hard tissues after one year in function: suppuration on probing
Time frame: 12 months
To observe the stability of the soft and hard tissues after one year in function: Modified plaque index (MPI)
Time frame: 12 months
Assessment of survival rate of the implants
Time frame: 12 months
Assessment of the success of the implants
Time frame: 12 months
Analyze the degree of patient satisfaction with the aesthetic result.
Time frame: 12 months
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 27 Jul 2023.
- 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 24818207Patil RC, den Hartog L, van Heereveld C, Jagdale A, Dilbaghi A, Cune MS. Comparison of two different abutment designs on marginal bone loss and soft tissue development. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):675-81. doi: 10.11607/jomi.3363.
- Background: PubMed 32559035Froum SJ, Natour M, Cho SC, Yu PYC, Leung M. Expanded Clinical Applications of Narrow-Diameter Implants for Permanent Use. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):529-537. doi: 10.11607/prd.4565.
- Background: PubMed 33548077Roccuzzo A, Imber JC, Jensen SS. Need for lateral bone augmentation at two narrow-diameter implants: A prospective, controlled, clinical study. Clin Oral Implants Res. 2021 Apr;32(4):511-520. doi: 10.1111/clr.13721. Epub 2021 Mar 1.
- Background: PubMed 3507627Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Background: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- Background: PubMed 2099210Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
- Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Derived from this study: PubMed 38443879Herrera-Perez P, Garcia-De-La-Fuente AM, Andia-Larrea E, Marichalar-Mendia X, Aguirre-Urizar JM, Aguirre-Zorzano LA. Clinical analysis of the tooth-implant papilla for two narrow-diameter titanium-zirconium implants in the anterior area: prospective controlled clinical study. BMC Oral Health. 2024 Mar 5;24(1):310. doi: 10.1186/s12903-024-04075-2.
- Individual participant dataSharing planned: Yes. The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will only be used for the purposes of this project.
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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.
ANA MARIA GARCIA DE LA FUENTE, PhD principal investigator
University of the Basque Country (UPV/EHU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oval section abutment of 2.9 mm and Circular section abutment of 3.3 mm in people with Dental Implants, run by Ana María García de la Fuente at 1 site in Spain.
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 5 inclusion and 4 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 27 Jul 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The main objective was the papillary index (PI) (Jemt, 1997) (time frame: 12 months). 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 NCT05642520, which also lists 9 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 27 Jul 2023.