Peri-implant Mucosa ThicknessNCT06880185
Soft Tissue Management in Peri-Implant Regions
A study testing Connective Tissue Graft and Ribose Cross-Linked Thick Collagen Membrane in people with Peri-implant Mucosa Thickness and Peri-implant Mucosa Width, run by Ömer Alperen Kırmızıgül at 1 site in Turkey (Türkiye).
Trial summary
Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucosa Thickness, Peri-implant Mucosa Width, Peri-Implant Tissues
- What is being tested?
- Connective Tissue Graft and Ribose Cross-Linked Thick Collagen Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Dec 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy
- The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
- Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
- Age between 18-60 years
- Does not have a condition that may cause a bleeding disorder
- No nausea-vomiting reflex
- Patients with good oral hygiene
Who cannot join
- Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
- Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
- Patients with collagen allergy
- Those taking any medication that may affect wound healing
- Those with bleeding disorders
- Smokers who smoke more than 10 cigarettes a day
Show all 10Show fewer
- Poor oral hygiene
- Those with vomiting-nausea reflex
- Allergic to anti-inflammatory drugs
- Patients with pregnancy/breastfeeding status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ribose Cross-Linked Thick Collagen Membranes and Connective Tissue Grafts on Peri-Implant Tissue
Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.
Methods:Single implant sites were included in the study of 20 systemically healthy patients. All procedures were performed concurrently with implant placement; SCTG was administered in ten patients, and RCCM in the other ten. Before the operation, the PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and Oral Health Impact profile-14 (OHIP-14) scores were recorded on post-operative days 1, 3, and 7. At 1 and 3 months measurements were repeated.
Read more
Results:In terms of PIMT, an average increase of 1.87 mm was recorded in the RCCM group and 1.99 mm in the SCTG group. The rate of increase in PIMT was statistically similar in both the groups (p>0.05). The OHIP-14 and VAS scores were similar between the groups on days 1, 3, and 7. There was a decrease at 3 months in both the groups.
Conclusion:Within the limits of this study, RCCM provided a similar increase in PIMT as SCTG. RCCM is a promising alternative to SCTG for increasing the PIMT.
Keywords: Collagen, Connective tissue, Dental implants, Oral mucosa
- Being tested
- Connective Tissue Graft, Ribose Cross-Linked Thick Collagen Membrane
- Keywords
- Collagen membranes, Soft tissue, Peri-implant mucosa thickness, Peri-implant mucosa width, Connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue GraftOther
Implant treatment was performed in 20 patients with a single tooth deficiency and soft tissue deficiency in the horizontal direction in the edentulous site. All patients received bone-level titanium implants. Soft tissue augmentation was performed simultaneously with implant treatment. The group were divided into CTG , and 10 patients were randomly assigned to group.
Ribose Cross-Linked Thick Collagen MembraneOther
Implant treatment was performed in 20 patients with a single tooth deficiency and soft tissue deficiency in the horizontal direction in the edentulous site. All patients received bone-level titanium implants. Soft tissue augmentation was performed simultaneously with implant treatment. The groups were divided into RCCM, and 10 patients were randomly assigned to group.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Connective Tissue Graft Receives: Other: Connective Tissue Graft |
| Test | Active comparator | Ribose Cross-Linked Thick Collagen Membrane Receives: Other: Ribose Cross-Linked Thick Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant Mucosa Thickness
Changes in peri-implant mucosal thickness at baseline, month 1 and month 3
Measured: From the beginning to the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Dec 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Peri-implant Mucosa ThicknessStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömer Alperen Kırmızıgül
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Ömer Alperen Kırmızıgül, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880185
- Sponsor's protocol ID
- İNU-DHF-ŞMK-01
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, Tavelli L, Stefanini M, Barootchi S, Mazzotti C, Gori G, Wang HL. Classification of facial peri-implant soft tissue dehiscence/deficiencies at single implant sites in the esthetic zone. J Periodontol. 2019 Oct;90(10):1116-1124. doi: 10.1002/JPER.18-0616. Epub 2019 Jun 3.
PubMed 31087334Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
PubMed 31461778Vallecillo C, Toledano-Osorio M, Vallecillo-Rivas M, Toledano M, Rodriguez-Archilla A, Osorio R. Collagen Matrix vs. Autogenous Connective Tissue Graft for Soft Tissue Augmentation: A Systematic Review and Meta-Analysis. Polymers (Basel). 2021 May 31;13(11):1810. doi: 10.3390/polym13111810.
PubMed 34072698Tommasato G, Del Fabbro M, Oliva N, Khijmatgar S, Grusovin MG, Sculean A, Canullo L. Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis. Clin Oral Investig. 2024 May 5;28(5):300. doi: 10.1007/s00784-024-05684-5.
PubMed 38704784Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
PubMed 27310522Thoma DS, Strauss FJ, Mancini L, Gasser TJW, Jung RE. Minimal invasiveness in soft tissue augmentation at dental implants: A systematic review and meta-analysis of patient-reported outcome measures. Periodontol 2000. 2023 Feb;91(1):182-198. doi: 10.1111/prd.12465. Epub 2022 Aug 11.
PubMed 35950734Thoma DS, Strauss FJ. On the discrepancy between professionally assessed and patient-reported outcome measures. J Periodontal Implant Sci. 2022 Apr;52(2):89-90. doi: 10.5051/jpis.225202edi01. No abstract available.
PubMed 35505571Thoma DS, Gasser TJW, Hammerle CHF, Strauss FJ, Jung RE. Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading. J Periodontol. 2023 Feb;94(2):230-243. doi: 10.1002/JPER.22-0226. Epub 2022 Oct 28.
PubMed 35904229Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.
PubMed 36935199Tavelli L, Barootchi S, Rodriguez MV, Meneghetti PC, Mendonca G, Wang HL. Volumetric Outcomes of Peri-implant Soft Tissue Augmentation with a Xenogeneic Cross-Linked Collagen Scaffold: A Comparative Clinical Study. Int J Periodontics Restorative Dent. 2023 Jul-Aug;43(4):415-422. doi: 10.11607/prd.6058.
PubMed 37552200Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.
PubMed 32710810Subramanya AP, Prabhuji MLV. Synthetic mineral collagen composite bone graft with ribose cross linked collagen membrane for lateral ridge augmentation. J Indian Soc Periodontol. 2023 May-Jun;27(3):332-335. doi: 10.4103/jisp.jisp_306_22. Epub 2023 May 1.
PubMed 37346848Stefanini M, Barootchi S, Sangiorgi M, Pispero A, Grusovin MG, Mancini L, Zucchelli G, Tavelli L. Do soft tissue augmentation techniques provide stable and favorable peri-implant conditions in the medium and long term? A systematic review. Clin Oral Implants Res. 2023 Sep;34 Suppl 26:28-42. doi: 10.1111/clr.14150.
PubMed 37750532Slade GD, Spencer AJ. Social impact of oral conditions among older adults. Aust Dent J. 1994 Dec;39(6):358-64. doi: 10.1111/j.1834-7819.1994.tb03106.x.
PubMed 7832683Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.
PubMed 25644301
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ribose Cross-Linked Thick Collagen Membranes and Connective Tissue Grafts on Peri-Implant Tissue
- ClinicalTrials.gov ID
- NCT06880185
- Acronym / sponsor ID
- İNU-DHF-ŞMK-01
- Keywords
- Collagen membranes, Soft tissue, Peri-implant mucosa thickness, Peri-implant mucosa width, Connective tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ömer Alperen KırmızıgülUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Mar 2025 (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.
Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.
Methods:Single implant sites were included in the study of 20 systemically healthy patients. All procedures were performed concurrently with implant placement; SCTG was administered in ten patients, and RCCM in the other ten. Before the operation, the PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and Oral Health Impact profile-14 (OHIP-14) scores were recorded on post-operative days 1, 3, and 7. At 1 and 3 months measurements were repeated.
Results:In terms of PIMT, an average increase of 1.87 mm was recorded in the RCCM group and 1.99 mm in the SCTG group. The rate of increase in PIMT was statistically similar in both the groups (p>0.05). The OHIP-14 and VAS scores were similar between the groups on days 1, 3, and 7. There was a decrease at 3 months in both the groups.
Conclusion:Within the limits of this study, RCCM provided a similar increase in PIMT as SCTG. RCCM is a promising alternative to SCTG for increasing the PIMT.
Keywords: Collagen, Connective tissue, Dental implants, Oral mucosa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Connective Tissue GraftConnective Tissue Graft |
| Test | Active comparator | Other: Ribose Cross-Linked Thick Collagen MembraneRibose Cross-Linked Thick Collagen Membrane |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy
- The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
- Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
- Age between 18-60 years
- Does not have a condition that may cause a bleeding disorder
Key exclusion criteria (10 listed)
- Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
- Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
- Patients with collagen allergy
- Those taking any medication that may affect wound healing
- Those with bleeding disorders
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 |
|---|---|---|
| Connective Tissue GraftImplant treatment was performed in 20 patients with a single tooth deficiency and soft tissue deficiency in the horizontal direction in the edentulous site. All patients received bone-level titanium implants. Soft tissue augmentation was performed simultaneously with implant treatment. The group were divided into CTG , and 10 patients were randomly assigned to group. | Other | Control |
| Ribose Cross-Linked Thick Collagen MembraneImplant treatment was performed in 20 patients with a single tooth deficiency and soft tissue deficiency in the horizontal direction in the edentulous site. All patients received bone-level titanium implants. Soft tissue augmentation was performed simultaneously with implant treatment. The groups were divided into RCCM, and 10 patients were randomly assigned to group. | Other | Test |
Primary outcome
Peri-implant Mucosa Thickness
Time frame: From the beginning to the 3rd month
Changes in peri-implant mucosal thickness at baseline, month 1 and month 3
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 9 Dec 2025.
- Results publication: PubMed 31087334Zucchelli G, Tavelli L, Stefanini M, Barootchi S, Mazzotti C, Gori G, Wang HL. Classification of facial peri-implant soft tissue dehiscence/deficiencies at single implant sites in the esthetic zone. J Periodontol. 2019 Oct;90(10):1116-1124. doi: 10.1002/JPER.18-0616. Epub 2019 Jun 3.
- Results publication: PubMed 31461778Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
- Results publication: PubMed 34072698Vallecillo C, Toledano-Osorio M, Vallecillo-Rivas M, Toledano M, Rodriguez-Archilla A, Osorio R. Collagen Matrix vs. Autogenous Connective Tissue Graft for Soft Tissue Augmentation: A Systematic Review and Meta-Analysis. Polymers (Basel). 2021 May 31;13(11):1810. doi: 10.3390/polym13111810.
- Results publication: PubMed 38704784Tommasato G, Del Fabbro M, Oliva N, Khijmatgar S, Grusovin MG, Sculean A, Canullo L. Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis. Clin Oral Investig. 2024 May 5;28(5):300. doi: 10.1007/s00784-024-05684-5.
- Results publication: PubMed 27310522Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
- Results publication: PubMed 35950734Thoma DS, Strauss FJ, Mancini L, Gasser TJW, Jung RE. Minimal invasiveness in soft tissue augmentation at dental implants: A systematic review and meta-analysis of patient-reported outcome measures. Periodontol 2000. 2023 Feb;91(1):182-198. doi: 10.1111/prd.12465. Epub 2022 Aug 11.
- Results publication: PubMed 35505571Thoma DS, Strauss FJ. On the discrepancy between professionally assessed and patient-reported outcome measures. J Periodontal Implant Sci. 2022 Apr;52(2):89-90. doi: 10.5051/jpis.225202edi01. No abstract available.
- Results publication: PubMed 35904229Thoma DS, Gasser TJW, Hammerle CHF, Strauss FJ, Jung RE. Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading. J Periodontol. 2023 Feb;94(2):230-243. doi: 10.1002/JPER.22-0226. Epub 2022 Oct 28.
- Results publication: PubMed 36935199Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.
- Results publication: PubMed 37552200Tavelli L, Barootchi S, Rodriguez MV, Meneghetti PC, Mendonca G, Wang HL. Volumetric Outcomes of Peri-implant Soft Tissue Augmentation with a Xenogeneic Cross-Linked Collagen Scaffold: A Comparative Clinical Study. Int J Periodontics Restorative Dent. 2023 Jul-Aug;43(4):415-422. doi: 10.11607/prd.6058.
- Results publication: PubMed 32710810Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.
- Results publication: PubMed 37346848Subramanya AP, Prabhuji MLV. Synthetic mineral collagen composite bone graft with ribose cross linked collagen membrane for lateral ridge augmentation. J Indian Soc Periodontol. 2023 May-Jun;27(3):332-335. doi: 10.4103/jisp.jisp_306_22. Epub 2023 May 1.
- 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?
A study testing Connective Tissue Graft and Ribose Cross-Linked Thick Collagen Membrane in people with Peri-implant Mucosa Thickness and Peri-implant Mucosa Width, run by Ömer Alperen Kırmızıgül 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 7 inclusion and 10 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 9 Dec 2025. 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?
Peri-implant Mucosa Thickness (time frame: From the beginning to the 3rd month). 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 NCT06880185, which also lists 27 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 9 Dec 2025; AzTrials last refreshed its copy on 4 Nov 2026.