Mandibular Bone ResorptionNCT04582162
Comparison of Short Implant Assisted Mandibular Overdenture Designs
A study testing Unsplinted implants and Splinted implants in people with Mandibular Bone Resorption, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mandibular Bone Resorption
- What is being tested?
- Unsplinted implants and Splinted implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2018to 30 Sep 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients.
- Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
- Patients free from systemic diseases that contradict the use of dental implants.
- Patients with class I ridge relation.
- Patients with adequate zone of keratinized mucosa.
- Patients with U-shaped or square shaped arches
Who cannot join
- Non-compliant patients based on history.
- Heavy smokers.
- Senile patients (over 75 years) with impaired neuromuscular control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short Implant Assisted Mandibular Overdenture Designs (A Randomized Clinical Trial)
The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.
Read the detailed description
Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.
- Conditions
- Mandibular Bone Resorption
- Being tested
- Unsplinted implants, Splinted implants
- Keywords
- short implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsplinted implantsOther
Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.
Splinted implantsOther
Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.
| Study group | Role | What they receive |
|---|---|---|
| Unsplinted implants | Experimental | Not described Receives: Other: Unsplinted implants |
| Splinted implants | Active comparator | Not described Receives: Other: Splinted implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
Measured: up to 12 months
Peri-implant probing depth
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
Measured: up to 12 months
Clinical attachment loss
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Measured: up to 12 months
Gingival inflammation (Modified gingival index)
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were:
0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Measured: up to 12 months
Crestal bone loss
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Dec 2018
- Primary completion5 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mandibular Bone ResorptionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Ahmed Weheda, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptAhmed A Abdelhakim, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptMagued H Fahmy, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptNermeen A Rady, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582162
- Sponsor's protocol ID
- short implant in overdentures
- Status last verified
- Dec 2023
- First submitted
- 4 Oct 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):203-15. doi: 10.1111/j.1600-051X.2008.01271.x.
PubMed 18724851Bell RB, Blakey GH, White RP, Hillebrand DG, Molina A. Staged reconstruction of the severely atrophic mandible with autogenous bone graft and endosteal implants. J Oral Maxillofac Surg. 2002 Oct;60(10):1135-41. doi: 10.1053/joms.2002.34986.
PubMed 12378486Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.
PubMed 16392351Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.
PubMed 22034499Baggi L, Cappelloni I, Di Girolamo M, Maceri F, Vairo G. The influence of implant diameter and length on stress distribution of osseointegrated implants related to crestal bone geometry: a three-dimensional finite element analysis. J Prosthet Dent. 2008 Dec;100(6):422-31. doi: 10.1016/S0022-3913(08)60259-0.
PubMed 19033026Bernard JP, Szmukler-Moncler S, Pessotto S, Vazquez L, Belser UC. The anchorage of Branemark and ITI implants of different lengths. I. An experimental study in the canine mandible. Clin Oral Implants Res. 2003 Oct;14(5):593-600. doi: 10.1034/j.1600-0501.2003.120908.x.
PubMed 12969363Stellingsma C, Meijer HJ, Raghoebar GM. Use of short endosseous implants and an overdenture in the extremely resorbed mandible: a five-year retrospective study. J Oral Maxillofac Surg. 2000 Apr;58(4):382-7; discussion 387-8. doi: 10.1016/s0278-2391(00)90917-0.
PubMed 10759117
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Implant Assisted Mandibular Overdenture Designs (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04582162
- Acronym / sponsor ID
- short implant in overdentures
- Conditions
- Mandibular Bone Resorption
- Keywords
- short implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Oct 2020 (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 aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.
Detailed description
Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unsplinted implants | Experimental | Other: Unsplinted implants |
| Splinted implants | Active comparator | Other: Splinted implants |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completely edentulous patients.
- Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
- Patients free from systemic diseases that contradict the use of dental implants.
- Patients with class I ridge relation.
- Patients with adequate zone of keratinized mucosa.
Key exclusion criteria (3 listed)
- Non-compliant patients based on history.
- Heavy smokers.
- Senile patients (over 75 years) with impaired neuromuscular control.
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 |
|---|---|---|
| Unsplinted implantsPatients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture. | Other | Unsplinted implants |
| Splinted implantsPatients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture. | Other | Splinted implants |
Primary outcome
Implant stability
Time frame: up to 12 months
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
Peri-implant probing depth
Time frame: up to 12 months
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
Clinical attachment loss
Time frame: up to 12 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Gingival inflammation (Modified gingival index)
Time frame: up to 12 months
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were: 0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Crestal bone loss
Time frame: up to 12 months
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.
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 4 Dec 2023.
- Background: PubMed 18724851Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):203-15. doi: 10.1111/j.1600-051X.2008.01271.x.
- Background: PubMed 12378486Bell RB, Blakey GH, White RP, Hillebrand DG, Molina A. Staged reconstruction of the severely atrophic mandible with autogenous bone graft and endosteal implants. J Oral Maxillofac Surg. 2002 Oct;60(10):1135-41. doi: 10.1053/joms.2002.34986.
- Background: PubMed 16392351Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.
- Background: PubMed 22034499Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.
- Background: PubMed 19033026Baggi L, Cappelloni I, Di Girolamo M, Maceri F, Vairo G. The influence of implant diameter and length on stress distribution of osseointegrated implants related to crestal bone geometry: a three-dimensional finite element analysis. J Prosthet Dent. 2008 Dec;100(6):422-31. doi: 10.1016/S0022-3913(08)60259-0.
- Background: PubMed 12969363Bernard JP, Szmukler-Moncler S, Pessotto S, Vazquez L, Belser UC. The anchorage of Branemark and ITI implants of different lengths. I. An experimental study in the canine mandible. Clin Oral Implants Res. 2003 Oct;14(5):593-600. doi: 10.1034/j.1600-0501.2003.120908.x.
- Background: PubMed 10759117Stellingsma C, Meijer HJ, Raghoebar GM. Use of short endosseous implants and an overdenture in the extremely resorbed mandible: a five-year retrospective study. J Oral Maxillofac Surg. 2000 Apr;58(4):382-7; discussion 387-8. doi: 10.1016/s0278-2391(00)90917-0.
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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.
Ahmed Weheda, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Ahmed A Abdelhakim, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Magued H Fahmy, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsplinted implants and Splinted implants in people with Mandibular Bone Resorption, run by Nourhan M.Aly at 1 site in Egypt.
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 6 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 4 Dec 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 Egypt. 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?
Implant stability (time frame: up to 12 months). The study lists 5 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 NCT04582162, which also lists 7 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 4 Dec 2023.