Soft Tissue Management in Peri-Implant Regions

December 2, 2025 updated by: Ömer Alperen Kırmızıgül

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Malatya, Turkey (Türkiye)
        • Inonu Unıversity Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Poor oral hygiene
  • Those with vomiting-nausea reflex
  • Allergic to anti-inflammatory drugs
  • Patients with pregnancy/breastfeeding status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Connective Tissue Graft
Other: Connective Tissue Graft
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.
Active Comparator: Test
Ribose Cross-Linked Thick Collagen Membrane
Other: Ribose Cross-Linked Thick Collagen Membrane
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the beginning to the 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ömer Alperen Kırmızıgül

Collaborators

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • İNU-DHF-ŞMK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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