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NCT Number: NCT06529640

Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession

Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
  • age from 18 th 60 years.

Exclusion criteria

  • Smokers
  • patients with malposed or crowded teeth
  • pregnant and lactating women
  • patients using medications that could affect the periodontal status

Treatment and study plan

SCTG followed by coronally postionting flap

Procedure

The SCTG will be harvested from the palate followed by coronally postionting flap

periosteal flap followed by coronally postionting flap

Procedure

he periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap

Primary outcomes

  1. the percentage of root coverage (%RC)

    Time frame: at base line, 1 month and 3 months after treatment

    to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100

Secondary outcomes

  1. recession depth

    Time frame: at base line, 1 month and 3 months after treatment

    to measure vertical recession by UNC periodontal probe from cemento-enamel junction (CEJ) to the gingival margin.

  2. recession width

    Time frame: at base line, 1 month and 3 months after treatment

    to measure horizontal recession by UNC periodontal probe the distance between the CEJ and the gingival margin

  3. clinical attachment gain

    Time frame: at base line, 1 month and 3 months after treatment

    to measure the periodontal attachment gain after treatment by UNC periodontal probe subtracting the sulcus depth from the distance between the free gingival margin and the mucogingival junction.

  4. keratinized tissue gain

    Time frame: at base line, 1 month and 3 months after treatment

    measure the gain in keratinized gingivaby UNC periodontal probe from the most apical point of the gingival margin to the mucogingival junction (MGJ) at the middle buccal point.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

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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