Back to resultsTime Effect on the Predictability of Different Grafting for Gingival Recession RT 1
Primary Purpose
Gingival Recession Types One(RT1)
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
melatonin with collagen matrix
connective tissue graft (CTG)
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession Types One(RT1)
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.
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
collagen matrix
connective tissue graft (CTG)
Arm Description
melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
Outcomes
Primary Outcome Measures
interproximal clinical attachment level
measured from CEJ to base of pocket depth by using periodontal prob
Probing pocket depth (PPD)
from gingival margin to pocket depth measured by mm
Recession depth
measure from CEJ to gingival margin by mm
Secondary Outcome Measures
Keratinized tissue width
from free gingival groove to MGJ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05976451
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession Types One(RT1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
collagen matrix
Arm Type
Experimental
Arm Description
melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
Arm Title
connective tissue graft (CTG)
Arm Type
Active Comparator
Arm Description
connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
Intervention Type
Combination Product
Intervention Name(s)
melatonin with collagen matrix
Intervention Description
(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
Intervention Type
Combination Product
Intervention Name(s)
connective tissue graft (CTG)
Intervention Description
control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)
Primary Outcome Measure Information:
Title
interproximal clinical attachment level
Description
measured from CEJ to base of pocket depth by using periodontal prob
Time Frame
6-9 months
Title
Probing pocket depth (PPD)
Description
from gingival margin to pocket depth measured by mm
Time Frame
6-9 months
Title
Recession depth
Description
measure from CEJ to gingival margin by mm
Time Frame
6-9 months
Secondary Outcome Measure Information:
Title
Keratinized tissue width
Description
from free gingival groove to MGJ
Time Frame
6-9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
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