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

Primary Purpose

Thickening; Gingival

Status
Unknown status
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
platelet rich fibrin
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thickening; Gingival

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • College of Dentistry / University of BaghdadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

prf group

control group

Arm Description

prf membrane placement over implant site for gingival thickening

no prf placement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

keratinized tissue width
by using periodontal probe

Full Information

First Posted
April 24, 2021
Last Updated
April 24, 2021
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04864197
Brief Title
Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant
Official Title
Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thickening; Gingival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Third professional person apply PRF membrane.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prf group
Arm Type
Experimental
Arm Description
prf membrane placement over implant site for gingival thickening
Arm Title
control group
Arm Type
Experimental
Arm Description
no prf placement
Intervention Type
Biological
Intervention Name(s)
platelet rich fibrin
Other Intervention Name(s)
PRF
Intervention Description
prf membrane placement over implant site for gingival thickening
Primary Outcome Measure Information:
Title
measuring gingival thickness
Description
transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
keratinized tissue width
Description
by using periodontal probe
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hussain F Fakhr Aldeen, B.D.S
Phone
07725228696
Email
dentisth8@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zaid M Yasser, M.S.c
Phone
07810994677
Facility Information:
Facility Name
College of Dentistry / University of Baghdad
City
Baghdad
ZIP/Postal Code
10047
Country
Iraq
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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