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

Not Applicable

Completed

• Conditions: Gingival Recession

• Registration Number: NCT06453369
• Lead Sponsor: October 6 University

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.

Study Timeline

• Study Start: 2022-03-02
• Primary Completion: 2024-02-04
• Study Completion: 2024-02-04
• Study First Submitted: 2024-05-07
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
percentage of root coverage	1 month, 3 and 6 months	Percentage root coverage (%RC): calculated as (\[RD preoperative - RD postoperative\]/RD preoperative) × 100%.

Secondary Outcome Measures

Name	Time	Method
Probing depth (PD)	6 months	Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth. (baseline and after 6 months)
Plaque index (PI)	1 month, 3 and 6 months	Is used for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin.
Complete root coverage (CRC)	1 month, 3 and 6 months	The number of sites that resulted in 100% root coverage.
Recession Depth (RD)	1 month, 3 and 6 months	Measured in millimeters from the gingival margin at the midbuccal aspect of the root, to the CEJ or relative CEJ.
Recession width (RW)	1 month, 3 and 6 months	The horizontal distance between the bilateral gingival margins at the height of the CEJ. (mm)
Clinical attachment level (CAL)	6 months	Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth. (after 6 months)
Gingival Thickness (GT)	6 months	Measured in millimeters at the mid-buccal of the gingiva and 2 mm apical the gingival margin at the attached gingiva or the alveolar mucosa using a #15 endodontic reamer with a silicon disk stop.
Width of the keratinized tissue (KTW)	1 month, 3 and 6 months	Measured in millimeters at midbuccal aspect of the tooth from the gingival margin to the mucogingival junction.
Gingival index (GI)	1 month, 3 and 6 months	GI is measured according to Loe and Sillness and scored on a scale of 0 to 3.
Pain index (PN)	1 month, 3 and 6 months	Pain is recorded on a horizontal pain scale of 0-10, Pain index to be recorded by the patients at 9 am, 3pm, and 9 pm from the day of the surgery and for 3 weeks post-treatment.
Professional esthetic evaluation and patient-reported satisfaction	6 months	The esthetic outcome will be assessed post-operatively after 6 months by an independent second examiner (MS), who is blinded to the treatment assignment, in accordance with RES (30). The evaluation will be based on comparing digital photographs.; Five variables were assessed: 1. the level of gingival margin (GM); 2. marginal tissue contour (MTC); 3. soft tissue texture (STT); 4. muco-gingival junction alignment (MGJ); and; 5. gingival color (GC). A score of 0, 3, or 6 will be used for evaluation of GM, whereas a score of 0-1 will be used for each of the other variables. The ideal esthetic score will be 10.

Trial Locations

Locations (1)

6 October university; 🇪🇬 Giza, Egypt