Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft

NCT06207565 | Not Yet Recruiting

• 1 other identifier: IDCE.N6
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Due to the evolution of esthetic implant dentistry and tissue regeneration (hard and soft tissue), flap design plays a crucial role in the maintenance and regeneration of the marginal soft tissue and interdental papillae around dental implants. The present study aims to compare soft and hard tissue changes following immediate implant placement with ridge augmentation using the vestibular flap versus single flap approach.

Conditions

Immediate Implant Placement

Keywords

Immediate implant placement; Anterior Maxilla; Vestibular flap; single flap approach

Outcome Measures

Primary Outcomes (1)

• Volumetric analysis of labial contour

  To evaluate tissue volume changes, Intra oral scans of the esthetic zone will be obtained. Changes in the soft tissue profile will be calculated as the difference between the digitized surface outline of the different profiles at the given time of maturation of the site. All the images recorded by the intra-oral scanner will be transmitted to a 3D viewer software (Exocad Gmbh) to assess and compare the linear and volumetric changes in the labial soft tissue contour in comparison to the original, at 2, 4 and 6 mm from the pre-operative gingival margin. All the scans will be superimposed to the pre-operative scan using 3-point alignment method that ensure standardization of the images.

  12 months

Secondary Outcomes (3)

• Labio-palatal bone width

  12 months

• Mid facial recession

  12 months

• Interdental papillae height

  12 months

Study Arms (2)

Vestibular Flap Group

EXPERIMENTAL

Vestibular Flap with immediate implant placement, bone graft and customized healing abutment.

Procedure: Vestibular Flap Group

Single Flap Approach group

ACTIVE COMPARATOR

Single Flap approach with immediate implant placement, bone graft and customized healing abutment.

Procedure: Single Flap Approach group

Interventions

Vestibular Flap Group PROCEDURE

Achieving the vestibular flap, a 1-cm long horizontal vestibular access incision using a 15c blade 3-4mm apical to the mucogingival junction of the hopeless tooth, exposing the alveolar bone. Flap dissection in a coronal direction to detach the periosteum is completed, forming a sub-periosteal tunnel.

Vestibular Flap Group

Single Flap Approach group PROCEDURE

A modified envelope flap originally reported as an access flap for single implant insertion in areas of esthetic relevance will be performed. A sulcular incision on the labial aspect extending at least one tooth mesial and distal to the implant site (permitting enough accessibility for bone augmentation) is done. The flap is reflected by performing a split-thickness flap elevation starting from the interproximal incisions, leaving the anatomical papillae in situ. While the full-thickness flap elevation is performed on the labial aspect of the included surgical area, starting at the sulcus, and reaching at least 3 mm apical to the bone crest.

Single Flap Approach group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have one non-restorable maxillary anterior (Canine to Canine region) with sound adjacent teeth.
• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
• Buccal bone thickness less than 1mm assessed in CBCT with good apical bone for implant primary stability.
• Good oral hygiene
• Patient accepts to provide an informed consent.

You may not qualify if:

• Smokers
• Pregnant and lactating females.
• Medically compromised patients.
• Patients with active infection related at the site of implant/bone graft placement.
• Patients with untreated active periodontal diseases.
• Patients with parafunctional habits.

Sponsors & Collaborators

• Misr International University: lead

Central Study Contacts

Ahmed I Abo El Futtouh, Dr

CONTACT

+201019999983; ahmedkey7@hotmail.com

Inas M El-Zayat, Assoc.Prof

CONTACT

+01222361579; inas.elzayat@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director of implant speciality program

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share