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

NCT06091605 | Unknown Phase 4

• 1 other identifier: FD-ASU1255
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Soft Tissue Augmentation; Dental Implants

Outcome Measures

Primary Outcomes (1)

• Peri-implant soft tissue phenotype

  Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,

  Baseline, 3 Months & 6 Months

Secondary Outcomes (6)

• Postoperative pain

  At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient)

• Postoperative swelling

  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)

  At 6 months

• Esthetic satisfaction

  At 3 and 6 months

• Probing depth

  Baseline, 3 Months & 6 Months

Study Arms (2)

Omega roll envelope flap (OREF) technique

EXPERIMENTAL

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.

Envelope flap combined with a sub-epithelial connective tissue graft

ACTIVE COMPARATOR

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.

Interventions

Soft tissue augmentation around dental implants. PROCEDURE

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

Also known as: Soft tissue augmentation around dental implants using Envelope flap combined with a sub-epithelial connective tissue graft.

Envelope flap combined with a sub-epithelial connective tissue graft; Omega roll envelope flap (OREF) technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Amr M Saeed, Msc of Perio.

CONTACT

01111304015; amrsaeed92@gmail.com

Mohamed S Abd El Aziz

CONTACT

01002209759

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Researcher

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10