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

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ClinicalTrials.gov Identifier: NCT06044870
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Maha fawzy el sayed ali abd allah, Cairo University

Tracking Information
First Submitted Date  ICMJE September 12, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date September 21, 2023
Estimated Study Start Date  ICMJE September 2023
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2023)		 Recession depth reduction. [ Time Frame: 1 year ]
Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2023)
  • Mean root coverage [ Time Frame: 1 year ]
    (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
  • Recession depth [ Time Frame: 1 year ]
    Measured as the distance between the free gingival margin and the cemento-enamel junction .
  • Recession width [ Time Frame: 1 year ]
    Measured as the distance between the between the mesial gingival margin and distal gingival margin
  • Soft tissue thickness [ Time Frame: 1 year ]
    The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
  • Keratinized tissue width [ Time Frame: 1 year ]
    Measured as the distance between the gingival margin and the muco-gingival junction.
  • 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).
  • 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''.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gingival Recession
Intervention  ICMJE Procedure: Modified laterally stretched technique with a connective tissue graft.
Modified laterally stretched technique with a connective tissue graft.
Study Arms  ICMJE
  • 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, allowing to place the graft in a more coronal position and improving access and visibility.

    Intervention: Procedure: 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 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: Procedure: Modified laterally stretched technique with a connective tissue graft.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2023)		 26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06044870
Other Study ID Numbers  ICMJE 21021992
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Maha fawzy el sayed ali abd allah, Cairo University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cairo University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP