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Completed

NCT Number: NCT06880185

Soft Tissue Management in Peri-Implant Regions

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

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Key information

Conditions

Peri-implant Mucosa Thickness Peri-Implant Tissues Peri-implant Mucosa Width

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu Unıversity Faculty of Dentistry

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connective Tissue Graft

Other

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 Membrane

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ömer Alperen Kırmızıgül

Other

Collaborators

  • Inonu University

Registry information

Official study title

Effects of Ribose Cross-Linked Thick Collagen Membranes and Connective Tissue Grafts on Peri-Implant Tissue

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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