- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06044870
Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
- 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.
- deep recession sites more than 5 mm
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 of the deepest recession site, allowing to place the graft in a more coronal position and improving access and visibility. |
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 suspended suture anchored in the lingual gingiva (Aroca et al., 2010, 2013; Azzi et al, 2002, zuhr et al.,2009).
|
Modified laterally stretched technique with a connective tissue graft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recession depth reduction.
Time Frame: 1 year
|
Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean root coverage
Time Frame: 1 year
|
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
|
1 year
|
|
Recession depth
Time Frame: 1 year
|
Measured as the distance between the free gingival margin and the cemento-enamel junction .
|
1 year
|
|
Recession width
Time Frame: 1 year
|
Measured as the distance between the between the mesial gingival margin and distal gingival margin
|
1 year
|
|
Soft tissue thickness
Time Frame: 1 year
|
The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
|
1 year
|
|
Keratinized tissue width
Time Frame: 1 year
|
Measured as the distance between the gingival margin and the muco-gingival junction.
|
1 year
|
|
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).
|
1 year
|
|
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''.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21021992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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