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

Not Applicable

Completed

• Conditions: Thin Gingival Biotype
• Interventions: Other: Platelets Rich Fibrin (i-PRF / C-PRF)

• Registration Number: NCT05615155
• Lead Sponsor: Sajjad Ahmed Shakir

Brief Summary

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

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 Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-PRF	Platelets Rich Fibrin (i-PRF / C-PRF)	The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin
i-PRF	Platelets Rich Fibrin (i-PRF / C-PRF)	The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Baghdad; 🇮🇶 Baghdad, Alresafa, Iraq