Clinical trial NCT06453369: A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession
Official title: A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival recession
Modified tunnel technique
tunnel technique
connective tissue graft
minimally invasive
root coverage
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: percentage of root coverage
timeFrame: 1 month, 3 and 6 months
Secondary outcomes:
measure: Complete root coverage (CRC)
timeFrame: 1 month, 3 and 6 months
measure: Recession Depth (RD)
timeFrame: 1 month, 3 and 6 months
measure: Recession width (RW)
timeFrame: 1 month, 3 and 6 months
measure: Probing depth (PD)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Width of the keratinized tissue (KTW)
timeFrame: 1 month, 3 and 6 months
measure: Gingival Thickness (GT)
timeFrame: 6 months
measure: Plaque index (PI)
timeFrame: 1 month, 3 and 6 months
measure: Gingival index (GI)
timeFrame: 1 month, 3 and 6 months
measure: Pain index (PN)
timeFrame: 1 month, 3 and 6 months
measure: Professional esthetic evaluation and patient-reported satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: 6 October university
Study officials:
affiliation: O6U
name: Aslam Ashraf Mogahed, BDs
role: PRINCIPAL_INVESTIGATOR
References: