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Completed

NCT Number: NCT05615155

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad

Baghdad, Alresafa, 10011, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. measure the mean differences gain of GT&KTW

    Time frame: baseline and 3 months

    the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.

Secondary outcomes

  1. measure the mean difference gain of GT&KTW

    Time frame: baseline and 1 month

    the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.

Sponsors and collaborators

Lead sponsor

Sajjad Ahmed Shakir

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2022
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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