NCT05976451

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

November 29, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

March 12, 2023

Last Update Submit

November 23, 2023

Conditions

Gingival Recession Types One(RT1)

Outcome Measures

Primary Outcomes (3)

  • interproximal clinical attachment level

    measured from CEJ to base of pocket depth by using periodontal prob

    6-9 months

  • Probing pocket depth (PPD)

    from gingival margin to pocket depth measured by mm

    6-9 months

  • Recession depth

    measure from CEJ to gingival margin by mm

    6-9 months

Secondary Outcomes (1)

  • Keratinized tissue width

    6-9 months

Study Arms (2)

collagen matrix

EXPERIMENTAL

melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)

Combination Product: melatonin with collagen matrix

connective tissue graft (CTG)

ACTIVE COMPARATOR

connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)

Combination Product: connective tissue graft (CTG)

Interventions

melatonin with collagen matrixCOMBINATION_PRODUCT

(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)

collagen matrix
connective tissue graft (CTG)COMBINATION_PRODUCT

control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)

connective tissue graft (CTG)

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 12, 2023

First Posted

August 4, 2023

Study Start

October 1, 2020

Primary Completion

April 1, 2022

Study Completion

March 3, 2023

Last Updated

November 29, 2023

Record last verified: 2023-07

Locations

EG(1)