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

NCT06453369 | Completed

• 1 other identifier: 14-2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

gingival recession; Modified tunnel technique; tunnel technique; connective tissue graft; minimally invasive; root coverage

Outcome Measures

Primary Outcomes (1)

• percentage of root coverage

  Percentage root coverage (%RC): calculated as (\[RD preoperative - RD postoperative\]/RD preoperative) × 100%.

  1 month, 3 and 6 months

Secondary Outcomes (11)

• Complete root coverage (CRC)

  1 month, 3 and 6 months

• Recession Depth (RD)

  1 month, 3 and 6 months

• Recession width (RW)

  1 month, 3 and 6 months

• Probing depth (PD)

  6 months

• Clinical attachment level (CAL)

  6 months

Study Arms (2)

root coverage using novel Y shaped Tunnel with Connective tissue graft

EXPERIMENTAL

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.

Procedure: Y shaped Tunnel with Connective tissue graft

root coverage using MCAT with Connective tissue graft

ACTIVE COMPARATOR

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.

Procedure: Y shaped Tunnel with Connective tissue graft

Interventions

Y shaped Tunnel with Connective tissue graft 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; root coverage using novel Y shaped Tunnel with Connective tissue graft

Eligibility Criteria

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

You may qualify if:

• Age above 18 years old.
• The presence of Miller's class I gingival recession (25).
• Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
• Absence of a history of periodontal surgery at the involved sites in the last 12 months.
• History of compliance with oral hygiene instructions and periodontal recall.
• Sufficient palatal donor tissue thickness (\> 2mm).
• Clearly identifiable cemento-enamel-junction (CEJ)

You may not qualify if:

• Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).
• Pregnant and lactating women
• Current use of any form of tobacco.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

6 October university

Giza, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Aslam Ashraf Mogahed, BDs

  O6U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator. Aslam Ashraf Mogahed

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 11, 2024
• Study Start: March 2, 2022
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

EG (1)