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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06044870
Other study ID # 21021992
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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