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.

NCT ID: NCT03695549

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-10-31

Brief Summary

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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

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* 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

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention

CAF+ APRF

Group Type ACTIVE_COMPARATOR

CAF + (A-PRF)

Intervention Type PROCEDURE

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

control

CAF+SCTG

Group Type ACTIVE_COMPARATOR

CAF+SCTG

Intervention Type PROCEDURE

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

Interventions

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CAF + (A-PRF)

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

Intervention Type PROCEDURE

CAF+SCTG

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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heba samir

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba Samir Mhmoud, assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Manal M Hosny, professor

Role: STUDY_DIRECTOR

Cairo University

Engi A Mahmoud, assistant professor

Role: STUDY_CHAIR

Cairo University

Central Contacts

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heba samir mahmoud, assistant lecturer

Role: CONTACT

01222541606

Other Identifiers

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assistant lecturer

Identifier Type: -

Identifier Source: org_study_id

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