Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199118
Recruitment Status : Unknown
Verified June 2017 by Sarah Elbanna, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Elbanna, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: CAF +SCTG Other: platelet rich fibrin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: CAF+SCTG+PRF
Intervention: surgical procedure : coronally advanced flap + SCTG Intervention: membrane: platelet rich fibrin Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin(PRF)
Procedure: CAF +SCTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Other Name: CTG

Other: platelet rich fibrin
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 Name: PRF

Active Comparator: CAF+SCTG
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG Intervention: surgical procedure : coronally advanced flap + SCTG
Procedure: CAF +SCTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Other Name: CTG




Primary Outcome Measures :
  1. Recession depth [ Time Frame: baseline ]
    from the cemento-enamel junction (CEJ) to the margin of the gingiva at the midbuccal point of the teeth.

  2. Recession depth [ Time Frame: 3 months ]
    from the CEJ to the margin of the gingiva at the midbuccal point of the teeth.

  3. Recession depth [ Time Frame: 6 months ]
    from the CEJ to the margin of the gingiva at the midbuccal point of the teeth.


Secondary Outcome Measures :
  1. recession width [ Time Frame: baseline ]
    measured horizontally between two borders of the recession

  2. recession width [ Time Frame: 3 months ]
    measured horizontally between two borders of the recession

  3. recession width [ Time Frame: 6 months ]
    measured horizontally between two borders of the recession

  4. root coverage gain [ Time Frame: at 6 months ]
    (preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.

  5. probing depth [ Time Frame: baseline ]
    measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth

  6. probing depth [ Time Frame: 3 months ]
    measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth

  7. probing depth [ Time Frame: 6 months ]
    measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth

  8. clinical attachment level [ Time Frame: baseline ]
    measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth.

  9. clinical attachment level [ Time Frame: 3 months ]
    measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth.

  10. clinical attachment level [ Time Frame: 6 months ]
    measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth.

  11. gingival biotype [ Time Frame: baseline ]
    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

  12. gingival biotype [ Time Frame: 3 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

  13. gingival biotype [ Time Frame: 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

  14. width of keratinized gingiva [ Time Frame: baseline ]
    from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth

  15. width of keratinized gingiva [ Time Frame: 3 months ]
    from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth

  16. width of keratinized gingiva [ Time Frame: 6 months ]
    from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth

  17. patient satisfaction [ Time Frame: after 1 month ]
    printed yes/ no questionnaire with 3 questions

  18. root coverage esthetic score (RES) [ Time Frame: 6 months ]
    The RES system evaluates 5 variables 6 months after surgery: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point is used for each of the other variables

  19. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.

3) 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 .

7) Teeth with cervical restorations, abrasion


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199118


Contacts
Layout table for location contacts
Contact: Sarah ehab Elbanna +201000760002 srhelbanna@gmail.com

Sponsors and Collaborators
Cairo University

Publications:

Layout table for additonal information
Responsible Party: Sarah Elbanna, Assistant lecturer in the oral medicine and periodontology department, Cairo University
ClinicalTrials.gov Identifier: NCT03199118     History of Changes
Other Study ID Numbers: sarahelbanna84
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Elbanna, Cairo University:
root coverage
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy