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

Thin Gingival Biotype Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615155
• Other study ID #: Sajjad Ahmed Shakir
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thin Gingival Biotype

Intervention

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

Locations

Country	Name	City	State
Iraq	University of Baghdad	Baghdad	Alresafa

Sponsors (1)

Lead Sponsor	Collaborator
Sajjad Ahmed Shakir

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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