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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

CAF +SCTG

platelet rich fibrin

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring root coverage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAF+SCTG+PRF

CAF+SCTG

Arm Description

The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)

Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only

Outcomes

Primary Outcome Measures

Recession Depth

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 Outcome Measures

Recession Width

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.

Root Coverage Gain

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

Probing Depth

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.

Clinical Attachment Level

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

Gingival Biotype

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.

Width of Keratinized Gingiva

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.

Patient Satisfaction

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?

Root Coverage Esthetic Score (RES)

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

Post Operative Pain

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

Full Information

NCT ID

NCT03199118

First Posted

June 21, 2017

Last Updated

February 22, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03199118

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

root coverage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAF+SCTG+PRF

Arm Type

Experimental

Arm Description

Arm Title

CAF+SCTG

Arm Type

Active Comparator

Arm Description

Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only

Intervention Type

Procedure

Intervention Name(s)

CAF +SCTG

Other Intervention Name(s)

CTG

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

platelet rich fibrin

Other Intervention Name(s)

PRF

Intervention Description

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

Primary Outcome Measure Information:

Title

Recession Depth

Description

Time Frame

baseline-3 months-6 months

Secondary Outcome Measure Information:

Title

Recession Width

Description

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.

Time Frame

baseline-3 months-6 months

Title

Root Coverage Gain

Description

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

Time Frame

at 6 months

Title

Probing Depth

Description

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.

Time Frame

baseline-3 months-6 months

Title

Clinical Attachment Level

Description

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

Time Frame

baseline-3 months-6 months

Title

Gingival Biotype

Description

Time Frame

baseline-3 months-6 months

Title

Width of Keratinized Gingiva

Description

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.

Time Frame

baseline-3 months-6 months

Title

Patient Satisfaction

Description

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?

Time Frame

questionnaire given to the patient 6 months after the surgery

Title

Root Coverage Esthetic Score (RES)

Description

Time Frame

6 months

Title

Post Operative Pain

Description

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

Time Frame

after 2 weeks from surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Azza Ezzelarab

Organizational Affiliation

Professor of periodontics, Faculty of dentistry, Cairo university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Noha Ghallab

Organizational Affiliation

Professor of periodontics, Faculty of dentistry, Cairo university

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of dentistry

City

Cairo

ZIP/Postal Code

12345

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12516830

Citation

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Results Reference

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7928129

Citation

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PubMed Identifier

12516826

Citation

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Results Reference

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Citation

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Citation

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Citation

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Citation

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

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