A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession

NCT ID: NCT06453369

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2024-02-04

Brief Summary

Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

Detailed Description

The tunnel technique is an approach that optimizes esthetics and predictability because of its ability to avoid releasing critical papillae and maintaining a high level of vascularity at the surgical site to support the grafts. The tunnel technique has a minimally invasive nature since the interdental papillae are left intact and vertical incisions are not performed which results in better esthetics. This technique entailed the placement of a connective tissue graft in the tunnel. Complete graft coverage is not mandatory as long as the graft dimensions are sufficient to ensure its survival. Avoiding detachment of the highly fragile interdental soft tissue can minimize the risk of losing papilla height in critical esthetic areas, avoid scar formation, maximize the papillary and lateral blood supply to the underlying graft and better stabilize the graft for optimal wound healing Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

root coverage using novel Y shaped Tunnel with Connective tissue graft

Sulcular incision will be performed using 15c blade . Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. Micro periosteal elevator will be used to elevate the buccal aspect of both mesial and distal papillae of the affected tooth. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG will be inserted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.

Group Type: EXPERIMENTAL

Y shaped Tunnel with Connective tissue graft

Intervention Type: PROCEDURE

Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.

root coverage using MCAT with Connective tissue graft

The tunnel will be prepared with a full-thickness incision up to MGJ and as a split-thickness beyond MGJ using tunneling instruments to obtain a tension-free tunnel, allowing the insertion of the CTG, a delicate incision is performed at the level of interdental papillae and raised without detaching the tip of the papillae. The papillary regions will be detached in their buccal aspects. The adjacent papillae of the neighboring teeth will be involved in the preparation to ensure a coronal positioning of the flap. After planing, the graft will be inserted into the tunnel by a specific suture technique. The first suture will be inserted through the most distal recession part and the needle exits in the most medial part of the recession, second suture will be placed at the opposite side and the needle exits at the same medial recession. The buccal flap will be advanced coronally to cover CTG and secured with sling sutures. The donor CTG will stabilized to the underlying CT interproximally.

Group Type: ACTIVE_COMPARATOR

Y shaped Tunnel with Connective tissue graft

Intervention Type: PROCEDURE

Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.

Interventions

Y shaped Tunnel with Connective tissue graft

Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age above 18 years old.

2. The presence of Miller's class I gingival recession (25).

3. Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.

4. Absence of a history of periodontal surgery at the involved sites in the last 12 months.

5. History of compliance with oral hygiene instructions and periodontal recall.

6. Sufficient palatal donor tissue thickness (> 2mm).

7. Clearly identifiable cemento-enamel-junction (CEJ)

Exclusion Criteria

1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).

2. Pregnant and lactating women

3. Current use of any form of tobacco.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Aslam Ashraf Mogahed

principle investigator. Aslam Ashraf Mogahed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aslam Ashraf Mogahed, BDs

Role: PRINCIPAL_INVESTIGATOR

O6U

Locations

6 October university

Giza, , Egypt

Countries

Egypt

Other Identifiers

14-2022

Identifier Type: -

Identifier Source: org_study_id