Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1

• ClinicalTrials.gov Identifier: NCT05976451
• Recruitment Status: Completed
• First Posted: August 4, 2023
• Last Update Posted: November 29, 2023
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): mahetab mohamed abdel el wahab, Ain Shams University

Tracking Information

• First Submitted Date: March 12, 2023
• First Posted Date: August 4, 2023
• Last Update Posted Date: November 29, 2023
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2023)

• interproximal clinical attachment level [ Time Frame: 6-9 months ]
  measured from CEJ to base of pocket depth by using periodontal prob
• Probing pocket depth (PPD) [ Time Frame: 6-9 months ]
  from gingival margin to pocket depth measured by mm
• Recession depth [ Time Frame: 6-9 months ]
  measure from CEJ to gingival margin by mm

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 27, 2023)

Keratinized tissue width [ Time Frame: 6-9 months ]

from free gingival groove to MGJ

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
• Official Title: Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone
• Brief Summary: The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)
• Detailed Description: this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gingival Recession Types One(RT1)

Intervention

• Combination Product: melatonin with collagen matrix
  (CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
• Combination Product: connective tissue graft (CTG)
  control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)

Study Arms

• Experimental: collagen matrix
  melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
  Intervention: Combination Product: melatonin with collagen matrix
• Active Comparator: connective tissue graft (CTG)
  connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
  Intervention: Combination Product: connective tissue graft (CTG)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 27, 2023): 22
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 3, 2023
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
• patients >18 years old,
• Full mouth plaque index score <20%
• Systemically and periodontally healthy patients.

Exclusion Criteria:

• Smokers
• Patients with periodontitis stage III and IV were previous surgical treatment of GR,
• Pregnant or breastfeeding women; P
• Patients with para-functional habits or any source of occlusal trauma.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05976451
• Other Study ID Numbers: 1011
• 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
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: mahetab mohamed abdel el wahab, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ain Shams University
• Verification Date: July 2023