The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05976451
Recruitment Status : Completed
First Posted : August 4, 2023
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
mahetab mohamed abdel el wahab, Ain Shams University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment Phase
Gingival Recession Types One(RT1) Combination Product: melatonin with collagen matrix Combination Product: connective tissue graft (CTG) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : March 3, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: collagen matrix
melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
 Combination Product: melatonin with collagen matrix
(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
Active Comparator: connective tissue graft (CTG)
connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
 Combination Product: connective tissue graft (CTG)
control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. interproximal clinical attachment level [ Time Frame: 6-9 months ]
    measured from CEJ to base of pocket depth by using periodontal prob

  2. Probing pocket depth (PPD) [ Time Frame: 6-9 months ]
    from gingival margin to pocket depth measured by mm

  3. Recession depth [ Time Frame: 6-9 months ]
    measure from CEJ to gingival margin by mm


Secondary Outcome Measures :
  1. Keratinized tissue width [ Time Frame: 6-9 months ]
    from free gingival groove to MGJ


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05976451


Locations
Layout table for location information
Egypt
Ain Shams University
Cairo, Al Qahirah, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: mahetab mohamed abdel el wahab, lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT05976451    
Other Study ID Numbers: 1011
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: July 2023

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
 Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants