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Completed

NCT Number: NCT05782751

Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession

The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Malak Mohamed Shoukheba, Tanta, Egypt

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About this study

Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • lack of any related medical issues that contraindicate periodontal surgery,
  • optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
  • No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin),
  • Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.

Exclusion criteria

  • the presence of class V caries or restoration in the site to be treated,
  • previous mucogingival surgery at the selected site.
  • Teeth that are tilted, rotated, or have any occlusal abnormalities.
  • Smokers and pregnant patients were excluded from the participation.

Treatment and study plan

GROUPI

Procedure

10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)

Other names: free connective tissue graft, growth factors enhanced matrix 21s (GEM21s), coronally advanced flap

GROUP II

Procedure

10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)

Other names: collagen membrane, coronally advanced flap

Primary outcomes

  1. Recession width

    Time frame: up to 6 months

    the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months

  2. recession depth

    Time frame: up to 6 months

    The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months

  3. Height of keratinized tissue

    Time frame: up to 6 months

    distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months

  4. Gingival thickness (Gingival biotype)

    Time frame: up to 6 months

    measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively

  5. radiographic measurements of facial bone level, thickness and density

    Time frame: up to 6 months

    from cone beam CT radiography measured at baseline, and 6 months postoperative

  6. Percentage of root coverage

    Time frame: up to 6 months

    according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months

Secondary outcomes

  1. probing pocket depth

    Time frame: up to 6 months

    measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months

  2. clinical attachment level

    Time frame: up to 6 months

    measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months

  3. Digital measurements

    Time frame: up to 6 months

    all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative

  4. healing index

    Time frame: up to 6 months

    recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2023
Registry last updated
Mar 24, 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.

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