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Efficacy of C-PRF vs i-PRF in Thin Gingival Biotype Subjects

NCT ID: NCT05615155

Last Updated: 2023-11-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-11-01

Brief Summary

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Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.

Detailed Description

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Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.

Gingival biotype is an important clinical parameter that plays an important role in determining the gingival health in the future and the possibility of developing gingival recession or other gingival unhealthy condition that is related to thin gingival biotype.

Gingival biotype is consist of gingival thickness and keratinized tissue width, and its either thin or thick, and the later is more favourable to withstand the developing of gingival diseases and unhealthy condition, with this study we compare the effect of i-PRF injection which is approved in many previous clinical trials that it affects the gingival biotype and increases gingival thickness and the keratinized tissue width, and compare it to newly developed PRF generation (C-PRF) which is Concentrated Platelet Rich Fibrin.

Conditions

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Thin Gingival Biotype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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i-PRF

The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin

Group Type EXPERIMENTAL

Platelets Rich Fibrin (i-PRF / C-PRF)

Intervention Type OTHER

one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF

C-PRF

The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin

Group Type EXPERIMENTAL

Platelets Rich Fibrin (i-PRF / C-PRF)

Intervention Type OTHER

one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF

Interventions

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Platelets Rich Fibrin (i-PRF / C-PRF)

one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years and no systemic disease or pregnancy.
2. Non-smoker.
3. Subjects with clinically healthy intact periodontium; bleeding on probing (BOP)\<10%, probing pocket depth (PPD)≤3mm, intact periodontium (no probing attachment loss). (Chapple et al., 2018).
4. Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018).
5. No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth.
6. No blood-borne conditions.
7. Any symptoms of recent acute illness e.g., COVID-19.

Exclusion Criteria

1. Active orthodontic treatment.
2. Previous periodontal surgery.
3. Use of blood thinners.
4. Use of any drugs that might lead to gingival enlargement.
5. Attrition.
6. Gingival Recession.
7. Thick gingival biotype.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sajjad Ahmed Shakir

OTHER

Sponsor Role lead

Responsible Party

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Sajjad Ahmed Shakir

bachelor of dental surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sajjad ah Shakir, BDS

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

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University of Baghdad

Baghdad, Alresafa, Iraq

Site Status

Countries

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Iraq

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Sajjad Ahmed Shakir

Identifier Type: -

Identifier Source: org_study_id