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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Modified laterally stretched technique with a connective tissue graft.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified laterally stretched technique with a connective tissue graft.<br>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.<br>* Modified laterally stretched technique with a connective tissue graft.<br>|
| Active Comparator: Tunneling technique with connective tissue graft.<br>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.<br>* Modified laterally stretched technique with a connective tissue graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession depth reduction. | 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 | (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100 | 1 year | 
| Recession depth | Measured as the distance between the free gingival margin and the cemento-enamel junction . | 1 year | 
| Recession width | Measured as the distance between the between the mesial gingival margin and distal gingival margin | 1 year | 
| Soft tissue thickness | The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin. | 1 year | 
| Keratinized tissue width | Measured as the distance between the gingival margin and the muco-gingival junction. | 1 year | 
| 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 | 
| 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 |