NCT06091605

Evaluation of Omega Roll Envelope Flap for Soft Tissue Augmentation Around Osseointegrated Dental Implants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant soft-tissue dehiscences. Aim of the study: The aim of this study will be to evaluate the efficacy of the Omega roll envelope flap (OREF) technique compared to the conventional envelope split-thickness flap technique combined with an autogenous connective tissue graft, in enhancing Peri-implant soft tissue phenotype defined by the gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant.

Detailed description

Materials and Methods: 24 patients complaining of a single missing tooth in the with adjacent intact natural teeth and demanding replacing it with the best possible esthetics will be enrolled and recruited from the outpatient clinic, Faculty of Dentistry, Ain Shams University according to eligibility criteria. They will be randomly allocated to two equal groups. Group A (test group, n=12) will have a single implant placed after receiving non-surgical periodontal therapy and then after 12 weeks at the uncovering of the implant and placement of healing abutment, an Omega roll envelope flap (OREF) technique will be carried out for soft tissue augmentation, while Group B (control group, n=12) same procedures will be done but, soft tissue augmentation will be done by an envelope split-thickness flap combined with a sub-epithelial connective tissue graft. After 3 and 6 months Peri-implant soft tissue phenotype defined by gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant will be clinically assessed (1ry outcome). The 2ry outcomes will include comparing between the probing depth and clinical attachment level. Postoperative pain and swelling will be recorded by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be blinded. Data collected will be tabulated and statistically analyzed.

Conditions

• Soft Tissue Augmentation
• Dental Implants

Interventions

Type	Name	Description
PROCEDURE	Soft tissue augmentation around dental implants.	Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2023-10-19
• Last updated: 2023-10-19