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Completed

NCT Number: NCT06621433

Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession

The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.

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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

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gingival recession type 2 according to Cairo et al (2011).
  • Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
  • Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
  • Clinically thick gingival biotype (1mm < gingival thickness).
  • Anterior esthetic zone.

Exclusion criteria

  • Patients with gingival recession types 1 and 3 according to Cairo et al.
  • Inadequate amount of attached gingiva (AG < 2 mm).
  • Uncooperative patients.
  • Smoking more than 10 cigarettes per day.
  • Patients with known systemic conditions or taking medications that may affect soft tissue healing.
  • Pregnant and lactating women.
  • Patients with parafunctional habits.

Treatment and study plan

T-PRF with CAF

Other

Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.

SECTG with CAF

Other

Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.

Primary outcomes

  1. Probing depth

    Time frame: up to 6 months

    The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.

  2. Clinical attachment loss

    Time frame: up to 6 months

    Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe

  3. Recession width (RW)

    Time frame: up to 6 months

    Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe

  4. Recession height (RH)

    Time frame: up to 6 months

    It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe

  5. Width of keratinized gingiva (KT)

    Time frame: up to 6 months

    Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction

Sponsors and collaborators

Lead sponsor

Rizk Beshir

Other

Registry information

Official study title

Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 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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