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Soft Tissue Management in Peri-Implant Regions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06880185
Enrollment
20
Registered
2025-03-17
Start date
2023-12-01
Completion date
2024-12-30
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

OTHERConnective 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.

OTHERRibose 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.

Sponsors

Inonu University
CollaboratorOTHER
Ömer Alperen Kırmızıgül
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Peri-implant Mucosa ThicknessFrom the beginning to the 3rd monthChanges in peri-implant mucosal thickness at baseline, month 1 and month 3

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026