Soft Tissue Management in Peri-Implant Regions

NCT06880185 | Completed

• 1 other identifier: İNU-DHF-ŞMK-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

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

Keywords

Collagen membranes; Soft tissue; Peri-implant mucosa thickness; Peri-implant mucosa width; Connective tissue graft

Outcome Measures

Primary Outcomes (1)

• Peri-implant Mucosa Thickness

  Changes in peri-implant mucosal thickness at baseline, month 1 and month 3

  From the beginning to the 3rd month

Study Arms (2)

Control

OTHER

Connective Tissue Graft

Other: Connective Tissue Graft

Test

ACTIVE COMPARATOR

Ribose Cross-Linked Thick Collagen Membrane

Other: Ribose Cross-Linked Thick Collagen Membrane

Interventions

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.

Control

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.

Test

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ömer Alperen Kırmızıgül: lead
• Inonu University: collaborator

Study Sites (1)

Inonu Unıversity Faculty of Dentistry

Malatya, Turkey (Türkiye)

Location

Related Publications (27)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Prof Dr

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: December 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)