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

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

Study Overview

• Status: Recruiting
• Conditions: Thickening; Gingival
• Intervention / Treatment: Biological: platelet rich fibrin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hussain F Fakhr Aldeen, B.D.S; Phone Number: 07725228696; Email: dentisth8@gmail.com
• Study Contact Backup: Name: Zaid M Yasser, M.S.c; Phone Number: 07810994677

Study Locations

• Iraq
  • Baghdad, Iraq, 10047
    • Recruiting
    • College of Dentistry / University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prf group; prf membrane placement over implant site for gingival thickening	Biological: platelet rich fibrin; prf membrane placement over implant site for gingival thickening; Other Names: PRF
Experimental: control group; no prf placement	Biological: platelet rich fibrin; prf membrane placement over implant site for gingival thickening; Other Names: PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring gingival thickness	transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
keratinized tissue width	by using periodontal probe	6 months

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): July 15, 2020
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 24, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingival Overgrowth; Gingival Hyperplasia
• Other Study ID Numbers: U0005B2O

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No