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Platelet Rich Fibrin Versus Melatonin Around Dental Implants

Primary Purpose

Patients With Missing Teeth

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
dental implants with melatonin gel
Sponsored by
Misr University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients With Missing Teeth

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • Faculty of dentistry at MUST

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

dental implants alone

platelet rich fibrin

melatonin gel

Arm Description

dental implants alone

dental implants with platelet rich fibrin membrane

dental implants with melatonin gel around dental implants

Outcomes

Primary Outcome Measures

gingival thickness

Secondary Outcome Measures

bone density
marginal bone loss

Full Information

First Posted
October 12, 2022
Last Updated
October 19, 2023
Sponsor
Misr University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05593731
Brief Title
Platelet Rich Fibrin Versus Melatonin Around Dental Implants
Official Title
Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Misr University for Science and Technology

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Missing Teeth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dental implants alone
Arm Type
Other
Arm Description
dental implants alone
Arm Title
platelet rich fibrin
Arm Type
Active Comparator
Arm Description
dental implants with platelet rich fibrin membrane
Arm Title
melatonin gel
Arm Type
Active Comparator
Arm Description
dental implants with melatonin gel around dental implants
Intervention Type
Biological
Intervention Name(s)
dental implants with melatonin gel
Other Intervention Name(s)
dental implants with platelet rich fibrin
Intervention Description
platelet rich fibrin membrane around dental implants
Primary Outcome Measure Information:
Title
gingival thickness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
bone density
Time Frame
6 months
Title
marginal bone loss
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female as melatonin is sex prevalence
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: good oral hygiene participants, free of any systemic diseases, Patients' age ranged from 20 to 40 years old. Patients who can complete surgery and the study protocol. Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health. Exclusion Criteria: patients who had parafunctional habits, current and former smokers, pregnant lactating women unmotivated patients patients with psychological problems patients who were not able to follow the treatment protocol -
Facility Information:
Facility Name
Faculty of dentistry at MUST
City
Giza
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Platelet Rich Fibrin Versus Melatonin Around Dental Implants

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