Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting

• ClinicalTrials.gov Identifier: NCT06044870
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): Maha fawzy el sayed ali abd allah, Cairo University

Study Description

Brief Summary:

Regression analysis in a recent systematic review showed significantly greater mRC and CRC values when modifications are done to the TUN procedure to achieve more coronal advancement of the flap, coronal advancement also helps in covering the underlying graft for better recession coverage outcomes (Tavelli et al., 2018), limited data is present on the possible influence of a covered or partially uncovered graft. However, it has been suggested that minimal exposure of the CTG may aid not only in achieving CRC but also a harmonious gingival margin (John et al., 2015; Rasperini et al., 2011).

Condition or disease	Intervention/treatment	Phase
Gingival Recession	Procedure: Modified laterally stretched technique with a connective tissue graft.	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Modified Laterally Stretched Technique in the Gingival Recession Sites of the Lower Anterior Teeth (RT2) vs Tunneling With Connective Tissue Grafting in Both Techniques: A Randomized Clinical Trial
• Estimated Study Start Date: September 2023
• Estimated Primary Completion Date: September 2024
• Estimated Study Completion Date: November 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Modified laterally stretched technique with a connective tissue graft.; After the administration of local anesthesia, root planing of the exposed root surfaces will be performed by means of hand instruments. A partial thickness envelope is performed with tunneling instruments involving one or two teeth adjacent to the tooth, in case of a very thin biotype a complete thickness envelope could be done. Two horizontal incisions are done at the base of the papillae, allowing to place the graft in a more coronal position and improving access and visibility.	Procedure: Modified laterally stretched technique with a connective tissue graft.; Modified laterally stretched technique with a connective tissue graft.
Active Comparator: Tunneling technique with connective tissue graft.; Immediately before surgery, contact point composite stops were placed to prevent the collapse of the suspended sutures in the inter-proximal spaces.• The entire gingival papillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva. The anchorage in the lingual gingiva will be placed far apically. The suture must capture the buccal flap and graft to avail optimal stabilization (Aroca et al., 2010, 2013; Azzi et al, 2002).	Procedure: Modified laterally stretched technique with a connective tissue graft.; Modified laterally stretched technique with a connective tissue graft.

Outcome Measures

Primary Outcome Measures :

1. Recession depth reduction. [ Time Frame: 1 year ]
   Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.

Secondary Outcome Measures :

1. Mean root coverage [ Time Frame: 1 year ]
   (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
2. Recession depth [ Time Frame: 1 year ]
   Measured as the distance between the free gingival margin and the cemento-enamel junction .
3. Recession width [ Time Frame: 1 year ]
   Measured as the distance between the between the mesial gingival margin and distal gingival margin
4. Soft tissue thickness [ Time Frame: 1 year ]
   The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
5. Keratinized tissue width [ Time Frame: 1 year ]
   Measured as the distance between the gingival margin and the muco-gingival junction.
6. Esthetics (RES) score [ Time Frame: 1 year ]
   A system used to evaluate five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
7. patient satisfaction [ Time Frame: 1 year ]
   A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 'not at all'' to 7 ''very likely''.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

• Single or multiple RT2 gingival recession site/sites in the lower anterior teeth.
• Age >/= 18 years.
• Patients with healthy or treated periodontal conditions.
• Patients willing to participate in the study.
• Absence of uncontrolled medical conditions.
• Full mouth plaque score </= 20% (O'Leary 1972).
• Full mouth bleeding score <20% (Ainamo and Bay 1975).
• Patients with aesthetic concerns.

Exclusion Criteria:

• Pregnant or lactating females.
• Tobacco smoking.
• Uncontrolled medical conditions.
• Uncooperative patients or unable to complete the study.
• Patients treated with any medication known to cause gingival hyperplasia.
• No occlusal interferences.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Maha fawzy el sayed ali abd allah, assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT06044870
• Other Study ID Numbers: 21021992
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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