NCT04864197

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 24, 2021

Last Update Submit

April 24, 2021

Conditions

Thickening; Gingival

Outcome Measures

Primary Outcomes (1)

  • measuring gingival thickness

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

    6 months

Secondary Outcomes (1)

  • keratinized tissue width

    6 months

Study Arms (2)

prf group

EXPERIMENTAL

prf membrane placement over implant site for gingival thickening

Biological: platelet rich fibrin

control group

EXPERIMENTAL

no prf placement

Biological: platelet rich fibrin

Interventions

platelet rich fibrinBIOLOGICAL

prf membrane placement over implant site for gingival thickening

Also known as: PRF
control groupprf group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry / University of Baghdad

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Gingival Hyperplasia

Condition Hierarchy (Ancestors)

Gingival OvergrowthGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Hussain F Fakhr Aldeen, B.D.S

CONTACT

07725228696dentisth8@gmail.com

Zaid M Yasser, M.S.c

CONTACT

07810994677

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Third professional person apply PRF membrane.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist (MSc student)

Study Record Dates

First Submitted

April 24, 2021

First Posted

April 28, 2021

Study Start

December 19, 2019

Primary Completion

July 15, 2020

Study Completion

July 15, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)