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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05976451

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession Types One(RT1)	Combination Product: melatonin with collagen matrix Combination Product: connective tissue graft (CTG)	N/A

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

Study Type:

Interventional

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 :

Oct 1, 2020

Actual Primary Completion Date :

Apr 1, 2022

Actual Study Completion Date :

Mar 3, 2023

Arms and Interventions

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)

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

Primary Outcome Measures

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

Secondary Outcome Measures

Keratinized tissue width [6-9 months]
from free gingival groove to MGJ

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Al Qahirah	Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mahetab mohamed abdel el wahab, lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05976451

Other Study ID Numbers:

1011

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Gingival Recession

Melatonin

Study Results

No Results Posted as of Aug 4, 2023