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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06453369
• Other study ID #: 14-2022
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: February 4, 2024

Study information

• Verified date: June 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 4, 2024
• Est. primary completion date: February 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	6 October university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of root coverage	Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.	1 month, 3 and 6 months
Secondary	Complete root coverage (CRC)	The number of sites that resulted in 100% root coverage.	1 month, 3 and 6 months
Secondary	Recession Depth (RD)	Measured in millimeters from the gingival margin at the midbuccal aspect of the root, to the CEJ or relative CEJ.	1 month, 3 and 6 months
Secondary	Recession width (RW)	The horizontal distance between the bilateral gingival margins at the height of the CEJ. (mm)	1 month, 3 and 6 months
Secondary	Probing depth (PD)	Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth. (baseline and after 6 months)	6 months
Secondary	Clinical attachment level (CAL)	Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth. (after 6 months)	6 months
Secondary	Width of the keratinized tissue (KTW)	Measured in millimeters at midbuccal aspect of the tooth from the gingival margin to the mucogingival junction.	1 month, 3 and 6 months
Secondary	Gingival Thickness (GT)	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.	6 months
Secondary	Plaque index (PI)	Is used for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin.	1 month, 3 and 6 months
Secondary	Gingival index (GI)	GI is measured according to Loe and Sillness and scored on a scale of 0 to 3.	1 month, 3 and 6 months
Secondary	Pain index (PN)	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.	1 month, 3 and 6 months
Secondary	Professional esthetic evaluation and patient-reported satisfaction	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: the level of gingival margin (GM); marginal tissue contour (MTC); soft tissue texture (STT); muco-gingival junction alignment (MGJ); and; 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.	6 months