Platelet Rich Fibrin Versus Melatonin Around Dental Implants

October 19, 2023 updated by: Radwa Elsherif, Misr University for Science and Technology

Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial

Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 02
        • Faculty of dentistry at MUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. good oral hygiene participants,
  2. free of any systemic diseases,
  3. Patients' age ranged from 20 to 40 years old.
  4. Patients who can complete surgery and the study protocol.
  5. Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health.

Exclusion Criteria:

  1. patients who had parafunctional habits,
  2. current and former smokers, pregnant
  3. lactating women
  4. unmotivated patients
  5. patients with psychological problems
  6. patients who were not able to follow the treatment protocol -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: dental implants alone
Biological: dental implants with melatonin gel
platelet rich fibrin membrane around dental implants
Other Names:
  • dental implants with platelet rich fibrin
Active Comparator: platelet rich fibrin
dental implants with platelet rich fibrin membrane
Biological: dental implants with melatonin gel
platelet rich fibrin membrane around dental implants
Other Names:
  • dental implants with platelet rich fibrin
Active Comparator: melatonin gel
dental implants with melatonin gel around dental implants
Biological: dental implants with melatonin gel
platelet rich fibrin membrane around dental implants
Other Names:
  • dental implants with platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gingival thickness
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
bone density
Time Frame: 6 months
6 months
marginal bone loss
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

July 10, 2022

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 23, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Misprotocol

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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