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OpenTrials
Completed

NCT Number: NCT05976451

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

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)

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Key information

Conditions

Gingival Recession Types One(RT1)

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin with collagen matrix

Combination Product

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

connective tissue graft (CTG)

Combination Product

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

Primary outcomes

  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 outcomes

  1. Keratinized tissue width

    Time frame: 6-9 months

    from free gingival groove to MGJ

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 4, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.