Back to results

Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.

Primary Purpose

Gingival Recession

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CAF + (A-PRF)

CAF+SCTG

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring advanced platelet rich fibrin,A-PRF

Eligibility Criteria

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

Inclusion Criteria:

Systemically healthy patients 18 years old and older both males and females.
Good oral hygiene after phase I therapy.
Miller's class I or II gingival recession.
Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

Pregnant or lactating females.
Current Smokers.
Patients with any systemic disease that may affect the periodontal healing.
Teeth with endodontic treatment, buccal restoration or caries.
Patients with poor oral hygiene

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intervention

control

Arm Description

CAF+ APRF

CAF+SCTG

Outcomes

Primary Outcome Measures

root coverage

measured in millimeter

Secondary Outcome Measures

Gingival esthetics

Root coverage esthetic score

Recession width

measured in millimeter

Clinical attachment level

measured in millimeter

Width of keratinized gingiva

measured in millimeter

Probing depth

measured in millimeter

Gingival thickness

measured in millimeter

Post-operative pain

Visual analog scale (VAS) Questionnaire

Patient Satisfaction

Post-Surgical Patient Satisfaction Questionnaire

Early wound healing

Early wound healing index

Full Information

NCT ID

NCT03695549

First Posted

October 1, 2018

Last Updated

October 6, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03695549

Brief Title

Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.

Official Title

Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2018 (Anticipated)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

October 2019 (Anticipated)

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

Yes

5. Study Description

Brief Summary

patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results. Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.

Detailed Description

Population (P): Patients with single Miller class I, II gingival recessions. Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF). Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG). Primary Outcome (O): Root coverage (mm). Time frame: 9 months. Study design: Randomized controlled clinical trial. Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University

6. Conditions and Keywords

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

Gingival Recession

Keywords

advanced platelet rich fibrin,A-PRF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Active Comparator

Arm Description

CAF+ APRF

Arm Title

control

Arm Type

Active Comparator

Arm Description

CAF+SCTG

Intervention Type

Procedure

Intervention Name(s)

CAF + (A-PRF)

Intervention Description

advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .

Intervention Type

Procedure

Intervention Name(s)

CAF+SCTG

Intervention Description

cornally advanced flap plus subepithilial connective tissue graft harvested from the palate

Primary Outcome Measure Information:

Title

root coverage

Description

measured in millimeter

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Gingival esthetics

Description

Root coverage esthetic score

Time Frame

9 months

Title

Recession width

Description

measured in millimeter

Time Frame

9 months

Title

Clinical attachment level

Description

measured in millimeter

Time Frame

9 months

Title

Width of keratinized gingiva

Description

measured in millimeter

Time Frame

9 months

Title

Probing depth

Description

measured in millimeter

Time Frame

9 months

Title

Gingival thickness

Description

measured in millimeter

Time Frame

9 months

Title

Post-operative pain

Description

Visual analog scale (VAS) Questionnaire

Time Frame

measured daily for the first 2 weeks post- operatively.

Title

Patient Satisfaction

Description

Post-Surgical Patient Satisfaction Questionnaire

Time Frame

9 months

Title

Early wound healing

Description

Early wound healing index

Time Frame

1,2,4 weeks post- surgical

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Systemically healthy patients 18 years old and older both males and females. Good oral hygiene after phase I therapy. Miller's class I or II gingival recession. Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing. Cooperative patients able and accept to come for follow up appointments Exclusion Criteria: Pregnant or lactating females. Current Smokers. Patients with any systemic disease that may affect the periodontal healing. Teeth with endodontic treatment, buccal restoration or caries. Patients with poor oral hygiene

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

heba samir mahmoud, assistant lecturer

Phone

01222541606

heba227@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heba Samir Mhmoud, assistant lecturer

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manal M Hosny, professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Engi A Mahmoud, assistant professor

Organizational Affiliation

Cairo University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs