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

NCT05615155 | Completed DMC

• 1 other identifier: Sajjad Ahmed Shakir
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Thin Gingival Biotype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• measure the mean difference gain of GT&KTW

  baseline and 1 month

Study Arms (2)

i-PRF

EXPERIMENTAL

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

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

C-PRF

EXPERIMENTAL

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

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

Interventions

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

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

C-PRF; i-PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and no systemic disease or pregnancy.
• Non-smoker.
• 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).
• Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018).
• No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth.
• No blood-borne conditions.
• Any symptoms of recent acute illness e.g., COVID-19.

You may not qualify if:

• Active orthodontic treatment.
• Previous periodontal surgery.
• Use of blood thinners.
• Use of any drugs that might lead to gingival enlargement.
• Attrition.
• Gingival Recession.
• Thick gingival biotype.

Sponsors & Collaborators

• Sajjad Ahmed Shakir: lead

Study Sites (1)

University of Baghdad

Baghdad, Alresafa, 10011, Iraq

Location

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

• Sajjad ah Shakir, BDS

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: bachelor of dental surgery

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: February 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)