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Status unknownNCT04864197Updated Apr 28, 2021

Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant

A Phase 3 interventional study of platelet rich fibrin in Thickening; Gingival, sponsored by University of Baghdad. Status unknown at 1 site in Iraq. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University of Baghdad · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2019, registered Apr 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

we used prf with dental implant treatment to find out whether prf has an effect on increasing the soft tissue thickness and keratinized tissue width

Read the detailed description

Clinical oral implant related research is facing many interesting challenges. One of them is to create and maintain stable soft and hard tissues around osseointegrated oral implants.

It was suggested in a classic study that a minimum of 2 mm of keratinized mucosa (KM) around natural teeth is necessary to maintain gingival health. The lack of a sufficient wide zone of KM has been investigated as a potential contributing factor for peri- implant disease and therefore might influence the long- term success of oral implants.

Various studies have found a negative influence of the absence of KM on plaque accumulation. Oral implants with a narrow zone of KM (\<2 mm) frequently exhibit significantly higher plaque scores than those with wider zones of KM. Even a subdivision can be made between KM and attached KM (AKM). A statistically significant higher plaque accumulation and gingival inflammation around implants in the groups with KM \<2 mm and AKM \<1 mm was observed. However, this could not be confirmed in another study.

Interestingly, the presence of an adequate band of KM adjacent to the implant seems to reduce inflammation, hyperplasia and recession of the marginal peri- implant soft tissues. Furthermore, it might facilitate restorative procedures, improve aesthetics and enable the patient to maintain an adequate oral hygiene without irritation or discomfort.

In particular, in the lower jaw, a scarce amount of KM can be regularly encountered. A reduced height of the alveolar process, due to crestal bone resorption, result in loss of KM due to the reduced distance between the bone crest and "genetically defined" position of the mucogingival line. Notably, in the posterior segments of the lower jaw, a narrow KM might be related to muscle pull, high frenulum attachments and a shallow vestibule.

Today, the golden standard to augment KM is a free gingival graft (FGG) harvested from the palate. The main problem with this technique is the morbidity for the patient as it involves a second surgical site. Reported problems following FGG procedure are pain, change in diet, paresthesia, herpetic lesion, mucocele, arteriovenous shunt and excessive bleeding.

To overcome this problem, different authors have proposed alternative techniques and materials to augment keratinized tissue around teeth and oral implants.

Various studies have substantiated the viability of platelet concentrates on enhancement of osseous and associated tissue healing and PRF is one of the recent innovations of various platelet concentrates.

Platelet- rich fibrin (PRF) is a 2nd generation platelet concentrate, which was introduced by Choukroun et al in 2001. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Its 3- dimensional fibrin network promotes neovascularization, accelerates wound closing and fast cicatricle tissue remodeling. Platelet concentrates are considered a source of autologous growth factors that promote cell migration and proliferation. Given that PRF is produced without using any additive, the fibrin polymerization occurs in a physiological way, resulting in a similar fibrin network as the one formed during natural healing.

Studies show a constant release of growth factors such as PDGF (platelet-derived growth factor) or TGF-b (transforming growth factor) for at least 1 week up to 28 days and proved its accelerating effect on the healing process.

02

Conditions studied

  • Thickening; Gingival
03

In context

Lead sponsor

University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients greater than 18 years old without systemic diseases and having good oral hygiene (with D1-D3 bone density).

Exclusion criteria

Exclusion Criteria:

  • general contraindications to implant surgery.
  • patients with a history of severe periodontitis.
  • bone augmentation required.
  • smokers.
  • treated or under treatment with intravenous aminobisphosphonates.
  • pregnant or lactating.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    prf group

    prf membrane placement over implant site for gingival thickening

    Biological: platelet rich fibrin

  • Experimental
    control group

    no prf placement

    Biological: platelet rich fibrin

Interventions

  • Biologicalplatelet rich fibrin

    prf membrane placement over implant site for gingival thickening

    Also known as: PRF

06

What researchers measure

Primary outcomes

  1. measuring gingival thickness

    transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness

    Time frame: 6 months

Secondary outcomes

  1. keratinized tissue width

    by using periodontal probe

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • College of Dentistry / University of Baghdad
    Baghdad, 10047, Iraq
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04864197
Lead sponsor
University of Baghdad
Responsible party
Hussain Falah Mohsen (dentist (MSc student), University of Baghdad) — Principal investigator
First posted
Apr 28, 2021
Start date
Dec 19, 2019
Primary completion
Jul 15, 2020
Completion
Jul 15, 2021 (estimated)
Last update
Apr 28, 2021

Study contacts

Hussain F Fakhr Aldeen, B.D.S
Contact
dentisth8@gmail.com
07725228696
Zaid M Yasser, M.S.c
Contact
07810994677

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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