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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Soft Tissue Augmentation; Dental Implants
• Intervention / Treatment: Procedure: Soft tissue augmentation around dental implants.

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amr M Saeed, Msc of Perio.; Phone Number: 002- 01111304015; Email: amrsaeed92@gmail.com
• Study Contact Backup: Name: Mohamed S Abd El Aziz; Phone Number: 002- 01002209759

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically free patients (American Society of Anesthesiologists (ASA) I. Patients between 18 - 50 years of both genders and able to understand the nature of the proposed surgery and to sign the informed consent. Ability to comply with the study related procedures such as maintaining good oral hygiene and attending all follow-up scheduled appointments. Patients who complained of a single missing tooth bounded with two adjacent natural sound teeth diagnosed with clinical periodontal health. Necessity for soft tissue augmentation in a single tooth gap determined by a concavity that was present in the edentulous area or tissues with thin biotype being ≤2 mm or with inadequate width of ≤4mm. Adequate bone width for implant placement without need for bone augmentation (confirmed by a single pre-operative cone-beam computed tomography) (CBCT).

Exclusion Criteria:

• Previous soft tissue augmentation in the area. Need for major soft or hard tissue augmentation procedures. Smokers. Patients taking medications that might affect the healing of soft and hard peri-implant tissues.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega roll envelope flap (OREF) technique; Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement. Omega roll envelope flap (OREF) technique will be done around the placed healing abutment, then suturing will be done.	Procedure: Soft tissue augmentation around dental implants.; Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique.; Other Names: Soft tissue augmentation around dental implants using Envelope flap combined with a sub-epithelial connective tissue graft.
Active Comparator: Envelope flap combined with a sub-epithelial connective tissue graft; Patients will undergo peri-implant soft tissue augmentation procedures accompanied by the placement of healing abutments at the uncovering of the inserted osseo-integrated implants, 12 weeks after the initial stage of implant placement. An envelope split thickness flap will be made at the concerned implant site and a connective tissue graft will be harvested from the tuberosity and then adapted to the placed healing abutment at the surgical site and suturing will be done.	Procedure: Soft tissue augmentation around dental implants.; Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique.; Other Names: Soft tissue augmentation around dental implants using Envelope flap combined with a sub-epithelial connective tissue graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant soft tissue phenotype	Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,	Baseline, 3 Months & 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Numerical rating scale (Visual analog scale) Scores (0-10)	At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient)
Postoperative swelling	Numerical rating scale (Visual analog scale) Scores (0-10)	At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient)
Implant soft tissue deficiency Esthetic Score (IDES)	Scores of: Soft Tissue Margin (STM) (0-5): 0= No improvement of the PSTD and 5=Complete coverage of the metallic components with the mucosal margin at the same level of the homologous tooth.; Peri-implant papillae height (PPH) (0-3): 0=Both papillae are more apical than the healthiest papilla tip of the homologous tooth and 3=Both papillae are at the same level (or more coronal) of the healthiest papilla tip of the homologous tooth.; Peri-implant Mucosa (PMC) (0-1): 0=Distinguishable from the adjacent soft tissue and 1=Not distinguishable from the adjacent soft tissue.; Peri-implant Mucosa Appearance (PMA) (0-1): 0=Presence of at least one of these conditions: scar tissue, MGJ not-aligned, tissue volume too thin or too thick compared to the adjacent soft tissue or tissue texture not similar to the adjacent soft tissue and 1=Absence of scar tissue, MGJ well aligned, tissue volume in line with the adjacent soft tissue or tissue texture similar to the adjacent soft tissue.	At 6 months
Esthetic satisfaction	Numerical rating scale (Visual analog scale) Scores (0-10)	At 3 and 6 months
Probing depth	Using UNC-15 Periodontal Probe	Baseline, 3 Months & 6 Months
Clinical Attachment Level (CAL)	Using UNC-15 Periodontal Probe 0mm= Normal <1-2mm= Stage 1 Periodontitis <3-4mm= Stage 2 Periodontitis >5mm= Stage 3 and 4 Perodontitis	Baseline, 3 Months & 6 Months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FD-ASU1255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No