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Completed

NCT Number: NCT05923294

Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

The primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.

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Key information

Conditions

Gingival Recession, Localized Attachment Loss, Periodontal Dentin Sensitivity Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Sensitivity, Tooth Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
  • Nonsmokers
  • Periodontally healthy patients
  • Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth

Exclusion criteria

  • Medically compromised patients, especially uncontrolled diabetes
  • Pregnancy, lactation, or suspicion of pregnancy,
  • Poor oral hygiene
  • Recessions associated with caries or restoration

Treatment and study plan

Coronally advanced flap with connective tissue graft

Procedure

In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

Primary outcomes

  1. Root coverage percentage

    Time frame: Postoperative 6th month

    The comparison of the postoperative recession depth to the initial recession depth

  2. Gingival thickness

    Time frame: Preoperative and postoperative 6th month

    Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings

Secondary outcomes

  1. Recession width

    Time frame: Preoperative and postoperative 6th month

    Recession width measured at the cemento-enamel junction

  2. Probing depth

    Time frame: Preoperative and postoperative 6th month

    Probing depth measured at the mid-buccal of the recession defect

  3. Clinical attachment loss

    Time frame: Preoperative and postoperative 6th month

    Clinical attachment loss measured at the mid-buccal of the recession defect

  4. Keratinized gingiva width

    Time frame: Preoperative and postoperative 6th month

    Mid-buccal gingival width measured with a periodontal probe

  5. Vestibular depth

    Time frame: Preoperative and postoperative 6th month

    The distance from the gingival margin to the greatest concavity of the mucosal fold

  6. Pain perception

    Time frame: Postoperative 1st week

    Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10

  7. Bleeding related to the procedure

    Time frame: Postoperative 1st week

    Bleeding evaluated by a dichotomous index

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2023
Registry last updated
Aug 13, 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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