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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044870
• Other study ID #: 21021992
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2023
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Modified laterally stretched technique with a connective tissue graft.
Modified laterally stretched technique with a connective tissue graft.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession depth reduction.	Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.	1 year
Secondary	Mean root coverage	(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100	1 year
Secondary	Recession depth	Measured as the distance between the free gingival margin and the cemento-enamel junction .	1 year
Secondary	Recession width	Measured as the distance between the between the mesial gingival margin and distal gingival margin	1 year
Secondary	Soft tissue thickness	The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.	1 year
Secondary	Keratinized tissue width	Measured as the distance between the gingival margin and the muco-gingival junction.	1 year
Secondary	Esthetics (RES) score	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).	1 year
Secondary	patient satisfaction	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''.	1 year