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

Efficacy of C-PRF Versus i-PRF on Gingival Thickness & Keratinized Tissue Width in Subjects With Thin Gingival Biotype: ( Split Mouth Controlled Clinical Trials)

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.

Study Overview

• Status: Completed
• Conditions: Thin Gingival Biotype
• Intervention / Treatment: Other: Platelets Rich Fibrin (i-PRF / C-PRF)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Alresafa
    • Baghdad, Alresafa, Iraq, 10011
      • University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-PRF; The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin	Other: 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
Experimental: C-PRF; The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure the mean differences gain of GT&KTW	the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure the mean difference gain of GT&KTW	the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.	baseline and 1 month

Collaborators and Investigators

• Sponsor: Sajjad Ahmed Shakir
• Investigators: Principal Investigator: Sajjad ah Shakir, BDS, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Sajjad Ahmed Shakir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the study will be published and shared for other researchers in medical journals.
• IPD Sharing Time Frame: it will be available in 2023/2024 and for no limits

IPD Sharing Access Criteria

data will be sent in e-mail for anyone wishes to access.

sajjad.shakir1959@gmail.com

• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No