Back to resultsClinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
Primary Purpose
Gingival Recession
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Modified laterally stretched technique with a connective tissue graft.
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified laterally stretched technique with a connective tissue graft.
Tunneling technique with connective tissue graft.
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Recession depth reduction.
Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.
Secondary Outcome Measures
Mean root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
Recession depth
Measured as the distance between the free gingival margin and the cemento-enamel junction .
Recession width
Measured as the distance between the between the mesial gingival margin and distal gingival margin
Soft tissue thickness
The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
Keratinized tissue width
Measured as the distance between the gingival margin and the muco-gingival junction.
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).
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''.
Full Information
NCT ID
NCT06044870
First Posted
September 12, 2023
Last Updated
September 18, 2023
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT06044870
Brief Title
Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified laterally stretched technique with a connective tissue graft.
Arm Type
Experimental
Arm Description
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.
Arm Title
Tunneling technique with connective tissue graft.
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Modified laterally stretched technique with a connective tissue graft.
Intervention Description
Modified laterally stretched technique with a connective tissue graft.
Primary Outcome Measure Information:
Title
Recession depth reduction.
Description
Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean root coverage
Description
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
Time Frame
1 year
Title
Recession depth
Description
Measured as the distance between the free gingival margin and the cemento-enamel junction .
Time Frame
1 year
Title
Recession width
Description
Measured as the distance between the between the mesial gingival margin and distal gingival margin
Time Frame
1 year
Title
Soft tissue thickness
Description
The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
Time Frame
1 year
Title
Keratinized tissue width
Description
Measured as the distance between the gingival margin and the muco-gingival junction.
Time Frame
1 year
Title
Esthetics (RES) score
Description
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).
Time Frame
1 year
Title
patient satisfaction
Description
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''.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
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