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Completed

NCT Number: NCT03199118

Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry

Cairo, 12345, Egypt

About this study

The study population will be divided into 2 groups:

Group 1:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years

Group 2:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.
  • Clinical indication and/or patient request for recession coverage 4) Good oral hygiene

Exclusion criteria

  • 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .
  • Teeth with cervical restorations, abrasion

Treatment and study plan

CAF +SCTG

Procedure

the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession

Other names: CTG

platelet rich fibrin

Other

in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession

Other names: PRF

Primary outcomes

  1. Recession Depth

    Time frame: baseline-3 months-6 months

    measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.

Secondary outcomes

  1. Recession Width

    Time frame: baseline-3 months-6 months

    It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.

  2. Root Coverage Gain

    Time frame: at 6 months

    (preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.

  3. Probing Depth

    Time frame: baseline-3 months-6 months

    measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.

  4. Clinical Attachment Level

    Time frame: baseline-3 months-6 months

    measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).

  5. Gingival Biotype

    Time frame: baseline-3 months-6 months

    under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.

  6. Width of Keratinized Gingiva

    Time frame: baseline-3 months-6 months

    from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.

  7. Patient Satisfaction

    Time frame: questionnaire given to the patient 6 months after the surgery

    printed yes/ no questionnaire with 3 questions:

    • would you do this surgery again?
    • would you recommend this treatment to others?
    • are you satisfied with the results?

  8. Root Coverage Esthetic Score (RES)

    Time frame: 6 months

    The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES.

    minimum value:0 maximum value: 10 which means better outcome for RES

  9. Post Operative Pain

    Time frame: after 2 weeks from surgery

    Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Mar 22, 2021

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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