Peri-ImplantitisNCT04769609
Reconstructive Surgical Therapy of Peri-implantitis
An observational study of Peri-Implantitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- bioresorbable membrane
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 12 Feb 2021
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Presence of bleeding on probing (BOP) and/or suppuration (SUP) on gentle probing, and a radiographic marginal bone loss (MBL) ≥ 2 mm based on baseline radiographs taken at the time of prosthesis delivery with increased probing depth (PD) compared to previous examinations.
Who may be able to join
- age > 18 years,
- having at least one implant demonstrating two- or three-wall infrabony defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration,
- no implant mobility and no evidence of occlusal overload.
Who cannot join
- serious systemic diseases, medications or conditions that would contraindicate for periodontal surgery and compromise wound healing,
- a history of taking systemic antibiotic during the past 3 months, and
- placement, and prosthetic loading of implants within the past year.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, 06490
About this study
Official title: Reconstructive Surgical Therapy of Peri-implantitis: 3-year Results of a Randomized Clinical Trial
Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Surgical non-reconstructive approaches have been suggested to have limited effectiveness in terms of the resolution of inflammation in the long term. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. The aim of this study was to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or concentrated growth factor (CGF). A total of 52 patients who had at least one implant diagnosed with peri-implantitis and needed to be scheduled for reconstructive therapy of a peri-implant infrabony defect were included. Peri-implantitis case was defined as increased probing depth (PD) compared to previous examinations with bleeding on probing (BOP) and/or suppuration and radiographic evidence of peri-implant bone loss beyond crestal bone level changes resulting from initial bone remodeling. The patients were randomly assigned to receive a bone substitute filling in combination with either CM or CGF. Intrabony components were filled with a bone substitute (BioOss spongiosa granules; Geistlich, Wolhusen, Switzerland) and covered with a CM (Bio-Guide, Geistlich Biomaterials) or CGF membrane. The plaque index (PI), gingival index (GI), BOP, PD, clinical attachment level (CAL), mucosal recession (MR) and radiographic vertical defect depth (VDD) values were evaluated at 1 and 3 years postoperatively.
Read the detailed description
Peri-implantitis is a plaque-associated pathological disease affecting the soft and/or hard tissues surrounding a dental implant and clinically characterized by bleeding on probing (BOP) and/or suppuration (Supp), increased probing depths (PDs) and/or mucosal marginal recessions (MRs) in addition to radiographic marginal bone loss (MBL) compared to previous examinations. Considering the increasing numbers of patients undergoing restorative treatment through dental implants and the corresponding increase in the prevalence of peri-implantitis, it is imperative to perform effective treatment methods for the management of these conditions. On the basis of evidence, the most reliable and predictable treatment of peri-implantitis has not yet been described, moreover, if the disease is left untreated, it progresses in a non-linear accelerating manner. Hence, peri-implantitis has been considered to be a major, unpredictable and growing problem for clinicians.
Various treatment protocols of this challenging problem involving non-surgical approaches and surgical therapies with open flap debridement procedures, resective surgeries, or reconstructive modalities, which include the use of bone substitutes with or without a membrane, decontamination methods of implant surfaces, antimicrobial prescriptions whether to use submerged or non-submerged techniques, have been proposed. Although non-surgical interventions have been reported to be effective in reducing BOP and PDs in peri-implantitis sites, these therapies have appeared to be unpredictable for the management of peri-implantitis, especially in most severe cases. As another treatment option, surgical non-reconstructive approaches, i.e. open flap debridement and surface decontamination alone, have been suggested to have limited effectiveness in terms of the resolution of inflammation for the long-term outcomes. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. Several surgical augmentative therapy studies, including the use of bone substitutes with or without barrier membranes have demonstrated significant clinical and radiographic improvements for at least 3 years, especially in well-contained (three- or four-wall) intrabony defects. A systematic review evaluating long-term outcomes of reconstructive therapy for the management of peri-implantitis showed a mean PD reduction of 3 mm and a radiographic gain of 2.4 mm in bone level. However, as indicated by the last EFP Workshop, no evidence to support the superiority of a specific material, product or membrane in terms of long-term clinical outcomes of a reconstructive approach has been found. It has been strictly recommended that identification of peri-implantitis therapy success and disease resolution in the long-term management are required to allow adequate assessment of stable treatment outcomes.
Because of many studies indicating that growth factors have provided to transiently stimulate cells locally, accelerate angiogenesis, promote proliferation, differentiation, and regeneration, the additional use of them in the management of peri-implantitis has been proposed to improve the clinical outcomes and enhance soft and hard tissue regeneration. A recent systematic review and meta-analysis has been suggested that growth factors might be associated with better outcomes with regard to PD and BOP, whereas, they did not reveal statistically significant evidence for yielding additional benefits in the treatment of peri-implantitis. A randomized clinical trial (RCT) on the reconstructive surgical treatment of peri-implantitis evaluating concentrated growth factor (CGF) used as a bioresorbable barrier membrane in combination with a bone substitute, was performed recently by our study group and demonstrated significant improvements in both clinical and radiographic assessments at 1-year follow-up. Nevertheless, there is scarce information in the literature regarding the predictability and long-term stability of autologous growth factors in peri-implantitis management.
It is, therefore, the aim of this study to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or CGF, and moreover, to identify prognostic indicators influencing the long-term reconstructive surgical treatment outcome using a multilevel statistical model.
- Conditions
- Peri-Implantitis
- Being tested
- bioresorbable membrane
- Keywords
- peri-implantitis, biomaterials, surgical treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioresorbable membraneDevice
reconstructive surgical treatment of peri-implant bone defects
| Study group | Role | What they receive |
|---|---|---|
| Concentrated growth factor (CGF) group | Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CGF Receives: Device: bioresorbable membrane | |
| Collagen membrane (CM) group | Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CM Receives: Device: bioresorbable membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean vertical radiographic defect depth (VDD)
Radiographic vertical defect depth (VDD) was measured between the first bone-to-implant contact and the reference point at the coronal part of the implant body at both mesial and distal aspects of the implants.
Measured: Postoperative 3 years
Secondary outcomes (6)
Plaque index
Silness \& Löe plaque index (PI) marked with a score from 0 to 3 (0: absence of microbial plaque; 1: thin film of microbial plaque; 2: moderate accumulation with plaque in the sulcus; 3: large amount of plaque in sulcus or pocket along the free gingival margin)
Measured: Baseline, postoperative 1 and 3 years
Gingival index
Löe \& Silness index (GI) marked with a score from 0 to 3. (0: normal gingiva; 1: mild inflammation, 2: moderate inflammation, 3: severe inflammation)
Measured: Baseline, postoperative 1 and 3 years
Bleeding on probing (percent [%]) (BOP)
BOP was assessed according to presence or absence of bleeding 30 s after gentle probing
Measured: Baseline, postoperative 1 and 3 years
Probing depth (mm) (PD)
PD was measured as the distance from the mucosal margin to the bottom of the probeable pocket
Measured: Baseline, postoperative 1 and 3 years
Clinical attachment level (mm) (CAL)
Clinical attachment level (CAL) defined as PD+ mucosal recession.
Measured: Baseline, postoperative 1 and 3 years
Mucosal recession (mm) (MR)
Mucosal recession (MR) was measured as the distance from the mucosal margin and the implant abutment interface
Measured: Baseline, postoperative 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Sep 2020
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769609
- Sponsor's protocol ID
- GUDHKAEK.2021.01/4
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491Mercado F, Hamlet S, Ivanovski S. Regenerative surgical therapy for peri-implantitis using deproteinized bovine bone mineral with 10% collagen, enamel matrix derivative and Doxycycline-A prospective 3-year cohort study. Clin Oral Implants Res. 2018 Jun;29(6):583-591. doi: 10.1111/clr.13256. Epub 2018 May 16.
PubMed 29767434La Monaca G, Pranno N, Annibali S, Cristalli MP, Polimeni A. Clinical and radiographic outcomes of a surgical reconstructive approach in the treatment of peri-implantitis lesions: A 5-year prospective case series. Clin Oral Implants Res. 2018 Oct;29(10):1025-1037. doi: 10.1111/clr.13369. Epub 2018 Sep 28.
PubMed 30267445Tomasi C, Regidor E, Ortiz-Vigon A, Derks J. Efficacy of reconstructive surgical therapy at peri-implantitis-related bone defects. A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:340-356. doi: 10.1111/jcpe.13070.
PubMed 30667523Polymeri A, Anssari-Moin D, van der Horst J, Wismeijer D, Laine ML, Loos BG. Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study. Clin Oral Implants Res. 2020 Nov;31(11):1047-1060. doi: 10.1111/clr.13651. Epub 2020 Sep 9.
PubMed 32803798Renvert S, Roos-Jansaker AM, Persson GR. Surgical treatment of peri-implantitis lesions with or without the use of a bone substitute-a randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1266-1274. doi: 10.1111/jcpe.12986. Epub 2018 Aug 21.
PubMed 30003583Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.
PubMed 30328195Isehed C, Svenson B, Lundberg P, Holmlund A. Surgical treatment of peri-implantitis using enamel matrix derivative, an RCT: 3- and 5-year follow-up. J Clin Periodontol. 2018 Jun;45(6):744-753. doi: 10.1111/jcpe.12894. Epub 2018 Apr 26.
PubMed 29574866Khoury F, Keeve PL, Ramanauskaite A, Schwarz F, Koo KT, Sculean A, Romanos G. Surgical treatment of peri-implantitis - Consensus report of working group 4. Int Dent J. 2019 Sep;69 Suppl 2(Suppl 2):18-22. doi: 10.1111/idj.12505.
PubMed 31478576Roccuzzo M, Fierravanti L, Pittoni D, Dalmasso P, Roccuzzo A. Implant survival after surgical treatment of peri-implantitis lesions by means of deproteinized bovine bone mineral with 10% collagen: 10-year results from a prospective study. Clin Oral Implants Res. 2020 Aug;31(8):768-776. doi: 10.1111/clr.13628. Epub 2020 Jul 24.
PubMed 32559322Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Epub 2020 May 14.
PubMed 32410379Aghazadeh A, Persson RG, Renvert S. Impact of bone defect morphology on the outcome of reconstructive treatment of peri-implantitis. Int J Implant Dent. 2020 Jun 17;6(1):33. doi: 10.1186/s40729-020-00219-5.
PubMed 32548733Carcuac O, Derks J, Abrahamsson I, Wennstrom JL, Petzold M, Berglundh T. Surgical treatment of peri-implantitis: 3-year results from a randomized controlled clinical trial. J Clin Periodontol. 2017 Dec;44(12):1294-1303. doi: 10.1111/jcpe.12813. Epub 2017 Nov 10.
PubMed 28902426Khouly I, Pardinas-Lopez S, Ruff RR, Strauss FJ. Efficacy of growth factors for the treatment of peri-implant diseases: a systematic review and meta-analysis. Clin Oral Investig. 2020 Jul;24(7):2141-2161. doi: 10.1007/s00784-020-03240-5. Epub 2020 May 16.
PubMed 32418012Isler SC, Soysal F, Ceyhanli T, Bakirarar B, Unsal B. Efficacy of concentrated growth factor versus collagen membrane in reconstructive surgical therapy of peri-implantitis: 3-year results of a randomized clinical trial. Clin Oral Investig. 2022 Aug;26(8):5247-5260. doi: 10.1007/s00784-022-04493-y. Epub 2022 May 26.
PubMed 35618961
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Surgical Therapy of Peri-implantitis: 3-year Results of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04769609
- Acronym / sponsor ID
- GUDHKAEK.2021.01/4
- Conditions
- Peri-Implantitis
- Keywords
- peri-implantitis, biomaterials, surgical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 24 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.
Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Surgical non-reconstructive approaches have been suggested to have limited effectiveness in terms of the resolution of inflammation in the long term. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. The aim of this study was to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or concentrated growth factor (CGF). A total of 52 patients who had at least one implant diagnosed with peri-implantitis and needed to be scheduled for reconstructive therapy of a peri-implant infrabony defect were included. Peri-implantitis case was defined as increased probing depth (PD) compared to previous examinations with bleeding on probing (BOP) and/or suppuration and radiographic evidence of peri-implant bone loss beyond crestal bone level changes resulting from initial bone remodeling. The patients were randomly assigned to receive a bone substitute filling in combination with either CM or CGF. Intrabony components were filled with a bone substitute (BioOss spongiosa granules; Geistlich, Wolhusen, Switzerland) and covered with a CM (Bio-Guide, Geistlich Biomaterials) or CGF membrane. The plaque index (PI), gingival index (GI), BOP, PD, clinical attachment level (CAL), mucosal recession (MR) and radiographic vertical defect depth (VDD) values were evaluated at 1 and 3 years postoperatively.
Detailed description
Peri-implantitis is a plaque-associated pathological disease affecting the soft and/or hard tissues surrounding a dental implant and clinically characterized by bleeding on probing (BOP) and/or suppuration (Supp), increased probing depths (PDs) and/or mucosal marginal recessions (MRs) in addition to radiographic marginal bone loss (MBL) compared to previous examinations. Considering the increasing numbers of patients undergoing restorative treatment through dental implants and the corresponding increase in the prevalence of peri-implantitis, it is imperative to perform effective treatment methods for the management of these conditions. On the basis of evidence, the most reliable and predictable treatment of peri-implantitis has not yet been described, moreover, if the disease is left untreated, it progresses in a non-linear accelerating manner. Hence, peri-implantitis has been considered to be a major, unpredictable and growing problem for clinicians.
Various treatment protocols of this challenging problem involving non-surgical approaches and surgical therapies with open flap debridement procedures, resective surgeries, or reconstructive modalities, which include the use of bone substitutes with or without a membrane, decontamination methods of implant surfaces, antimicrobial prescriptions whether to use submerged or non-submerged techniques, have been proposed. Although non-surgical interventions have been reported to be effective in reducing BOP and PDs in peri-implantitis sites, these therapies have appeared to be unpredictable for the management of peri-implantitis, especially in most severe cases. As another treatment option, surgical non-reconstructive approaches, i.e. open flap debridement and surface decontamination alone, have been suggested to have limited effectiveness in terms of the resolution of inflammation for the long-term outcomes. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. Several surgical augmentative therapy studies, including the use of bone substitutes with or without barrier membranes have demonstrated significant clinical and radiographic improvements for at least 3 years, especially in well-contained (three- or four-wall) intrabony defects. A systematic review evaluating long-term outcomes of reconstructive therapy for the management of peri-implantitis showed a mean PD reduction of 3 mm and a radiographic gain of 2.4 mm in bone level. However, as indicated by the last EFP Workshop, no evidence to support the superiority of a specific material, product or membrane in terms of long-term clinical outcomes of a reconstructive approach has been found. It has been strictly recommended that identification of peri-implantitis therapy success and disease resolution in the long-term management are required to allow adequate assessment of stable treatment outcomes.
Because of many studies indicating that growth factors have provided to transiently stimulate cells locally, accelerate angiogenesis, promote proliferation, differentiation, and regeneration, the additional use of them in the management of peri-implantitis has been proposed to improve the clinical outcomes and enhance soft and hard tissue regeneration. A recent systematic review and meta-analysis has been suggested that growth factors might be associated with better outcomes with regard to PD and BOP, whereas, they did not reveal statistically significant evidence for yielding additional benefits in the treatment of peri-implantitis. A randomized clinical trial (RCT) on the reconstructive surgical treatment of peri-implantitis evaluating concentrated growth factor (CGF) used as a bioresorbable barrier membrane in combination with a bone substitute, was performed recently by our study group and demonstrated significant improvements in both clinical and radiographic assessments at 1-year follow-up. Nevertheless, there is scarce information in the literature regarding the predictability and long-term stability of autologous growth factors in peri-implantitis management.
It is, therefore, the aim of this study to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or CGF, and moreover, to identify prognostic indicators influencing the long-term reconstructive surgical treatment outcome using a multilevel statistical model.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated growth factor (CGF) group | – | Device: bioresorbable membraneReconstructive surgical therapy of peri-implantitis using a bone substitute combined with CGF |
| Collagen membrane (CM) group | – | Device: bioresorbable membraneReconstructive surgical therapy of peri-implantitis using a bone substitute combined with CM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Presence of bleeding on probing (BOP) and/or suppuration (SUP) on gentle probing, and a radiographic marginal bone loss (MBL) ≥ 2 mm based on baseline radiographs taken at the time of prosthesis delivery with increased probing depth (PD) compared to previous examinations.
Key inclusion criteria (3 listed)
- age > 18 years,
- having at least one implant demonstrating two- or three-wall infrabony defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration,
- no implant mobility and no evidence of occlusal overload.
Key exclusion criteria (3 listed)
- serious systemic diseases, medications or conditions that would contraindicate for periodontal surgery and compromise wound healing,
- a history of taking systemic antibiotic during the past 3 months, and
- placement, and prosthetic loading of implants within the past year.
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 |
|---|---|---|
| bioresorbable membranereconstructive surgical treatment of peri-implant bone defects | Device | Collagen membrane (CM) group, Concentrated growth factor (CGF) group |
Primary outcome
mean vertical radiographic defect depth (VDD)
Time frame: Postoperative 3 years
Radiographic vertical defect depth (VDD) was measured between the first bone-to-implant contact and the reference point at the coronal part of the implant body at both mesial and distal aspects of the implants.
6 secondary outcomes
Plaque index
Time frame: Baseline, postoperative 1 and 3 years
Gingival index
Time frame: Baseline, postoperative 1 and 3 years
Bleeding on probing (percent [%]) (BOP)
Time frame: Baseline, postoperative 1 and 3 years
Probing depth (mm) (PD)
Time frame: Baseline, postoperative 1 and 3 years
Clinical attachment level (mm) (CAL)
Time frame: Baseline, postoperative 1 and 3 years
Mucosal recession (mm) (MR)
Time frame: Baseline, postoperative 1 and 3 years
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 1 Mar 2021.
- Results publication: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Results publication: PubMed 29767434Mercado F, Hamlet S, Ivanovski S. Regenerative surgical therapy for peri-implantitis using deproteinized bovine bone mineral with 10% collagen, enamel matrix derivative and Doxycycline-A prospective 3-year cohort study. Clin Oral Implants Res. 2018 Jun;29(6):583-591. doi: 10.1111/clr.13256. Epub 2018 May 16.
- Results publication: PubMed 30267445La Monaca G, Pranno N, Annibali S, Cristalli MP, Polimeni A. Clinical and radiographic outcomes of a surgical reconstructive approach in the treatment of peri-implantitis lesions: A 5-year prospective case series. Clin Oral Implants Res. 2018 Oct;29(10):1025-1037. doi: 10.1111/clr.13369. Epub 2018 Sep 28.
- Results publication: PubMed 30667523Tomasi C, Regidor E, Ortiz-Vigon A, Derks J. Efficacy of reconstructive surgical therapy at peri-implantitis-related bone defects. A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:340-356. doi: 10.1111/jcpe.13070.
- Results publication: PubMed 32803798Polymeri A, Anssari-Moin D, van der Horst J, Wismeijer D, Laine ML, Loos BG. Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study. Clin Oral Implants Res. 2020 Nov;31(11):1047-1060. doi: 10.1111/clr.13651. Epub 2020 Sep 9.
- Results publication: PubMed 30003583Renvert S, Roos-Jansaker AM, Persson GR. Surgical treatment of peri-implantitis lesions with or without the use of a bone substitute-a randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1266-1274. doi: 10.1111/jcpe.12986. Epub 2018 Aug 21.
- Results publication: PubMed 30328195Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.
- Results publication: PubMed 29574866Isehed C, Svenson B, Lundberg P, Holmlund A. Surgical treatment of peri-implantitis using enamel matrix derivative, an RCT: 3- and 5-year follow-up. J Clin Periodontol. 2018 Jun;45(6):744-753. doi: 10.1111/jcpe.12894. Epub 2018 Apr 26.
- Results publication: PubMed 31478576Khoury F, Keeve PL, Ramanauskaite A, Schwarz F, Koo KT, Sculean A, Romanos G. Surgical treatment of peri-implantitis - Consensus report of working group 4. Int Dent J. 2019 Sep;69 Suppl 2(Suppl 2):18-22. doi: 10.1111/idj.12505.
- Results publication: PubMed 32559322Roccuzzo M, Fierravanti L, Pittoni D, Dalmasso P, Roccuzzo A. Implant survival after surgical treatment of peri-implantitis lesions by means of deproteinized bovine bone mineral with 10% collagen: 10-year results from a prospective study. Clin Oral Implants Res. 2020 Aug;31(8):768-776. doi: 10.1111/clr.13628. Epub 2020 Jul 24.
- Results publication: PubMed 32410379Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Epub 2020 May 14.
- Results publication: PubMed 32548733Aghazadeh A, Persson RG, Renvert S. Impact of bone defect morphology on the outcome of reconstructive treatment of peri-implantitis. Int J Implant Dent. 2020 Jun 17;6(1):33. doi: 10.1186/s40729-020-00219-5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 Mar 2021. 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 Turkey (Türkiye). 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?
mean vertical radiographic defect depth (VDD) (time frame: Postoperative 3 years). 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 NCT04769609, which also lists 15 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 1 Mar 2021.