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Platelet Rich Fibrin Versus Melatonin Around Dental Implants

Sponsor
Misr University for Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT05593731
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
8
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: melatonin gel
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial
Actual Study Start Date :
Dec 10, 2021
Actual Primary Completion Date :
Jul 10, 2022
Actual Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: dental implants alone

dental implants alone

Biological: melatonin gel
platelet rich fibrin membrane around dental implants
Other Names:
  • platelet rich fibrin

    		•
    Active Comparator: platelet rich fibrin

    platelet rich fibrin membrane around dental implants

    Biological: melatonin gel
    platelet rich fibrin membrane around dental implants
    Other Names:
  • platelet rich fibrin

    		•
    Active Comparator: melatonin gel

    melatonin gel around dental implants

    Biological: melatonin gel
    platelet rich fibrin membrane around dental implants
    Other Names:
  • platelet rich fibrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. gingival thickness [6 months]

    Secondary Outcome Measures

    1. bone density [6 months]

    2. marginal bone loss [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of dentistry at MUST Giza Egypt 02

    Sponsors and Collaborators

    • Misr University for Science and Technology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radwa Elsherif, lecturer of oral medicine, periodontology, oral diagnosis, Misr University for Science and Technology
    ClinicalTrials.gov Identifier:
    NCT05593731
    Other Study ID Numbers:
    • Misprotocol
    First Posted:
    Oct 25, 2022
    Last Update Posted:
    Oct 25, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tooth Loss
    Anodontia
    Melatonin

    Study Results

    No Results Posted as of Oct 25, 2022