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Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap
Nanocrystalline hydroxyapatite loaded in PRF
Nanocrystalline tricalcium phosphate loaded in PRF
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with good systemic health and no contraindication for periodontal surgery. Patients who are able to maintain good oral hygiene. Gingival thickness for the site selected should be ≥1mm. The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction). Exclusion Criteria: Active infectious diseases (hepatitis, tuberculosis, HIV, etc….). Medically compromised patients. Patients taking medications known to cause gingival enlargement. Pregnant patients and smokers. Previous mucogingival surgery at the defect. Restorations or caries in the area to be treated and non vital tooth. Teeth which are tilted or rotated.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Nanocrystalline hydroxyapatite

    Nanocrystalline tricalcium phosphate (NcTCP)

    Arm Description

    Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

    Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap

    Outcomes

    Primary Outcome Measures

    Recession height
    measurement recession height
    Recession width
    measurement of Recession width
    Height of the keratinized tissue
    measurement of Height of the keratinized tissue
    Percentage of root coverage
    It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
    Radiographic assessment
    measurement of buccal bone gain

    Secondary Outcome Measures

    Probing pocket depth
    measurement of Probing pocket depth
    Clinical attachment level
    measurement of Clinical attachment level

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 24, 2023
    Sponsor
    October 6 University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06016894
    Brief Title
    Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession
    Official Title
    Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2000 (Actual)
    Primary Completion Date
    September 20, 2022 (Actual)
    Study Completion Date
    April 22, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    October 6 University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.
    Detailed Description
    gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP) is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is one of the most popular and effective artificial bone substitutes. It is osteoinductive as well as osteoconductive. These characteristics enable full bone defects regeneration together with its cell-mediated resorption. In this study, we compared between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nanocrystalline hydroxyapatite
    Arm Type
    Active Comparator
    Arm Description
    Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap
    Arm Title
    Nanocrystalline tricalcium phosphate (NcTCP)
    Arm Type
    Active Comparator
    Arm Description
    Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap
    Intervention Description
    coronally advanced flap operation
    Intervention Type
    Other
    Intervention Name(s)
    Nanocrystalline hydroxyapatite loaded in PRF
    Intervention Description
    Nanocrystalline hydroxyapatite loaded in PRF
    Intervention Type
    Other
    Intervention Name(s)
    Nanocrystalline tricalcium phosphate loaded in PRF
    Intervention Description
    Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF
    Primary Outcome Measure Information:
    Title
    Recession height
    Description
    measurement recession height
    Time Frame
    6 months
    Title
    Recession width
    Description
    measurement of Recession width
    Time Frame
    6 months
    Title
    Height of the keratinized tissue
    Description
    measurement of Height of the keratinized tissue
    Time Frame
    6 months
    Title
    Percentage of root coverage
    Description
    It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
    Time Frame
    6 months
    Title
    Radiographic assessment
    Description
    measurement of buccal bone gain
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    measurement of Probing pocket depth
    Time Frame
    6 months
    Title
    Clinical attachment level
    Description
    measurement of Clinical attachment level
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with good systemic health and no contraindication for periodontal surgery. Patients who are able to maintain good oral hygiene. Gingival thickness for the site selected should be ≥1mm. The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction). Exclusion Criteria: Active infectious diseases (hepatitis, tuberculosis, HIV, etc….). Medically compromised patients. Patients taking medications known to cause gingival enlargement. Pregnant patients and smokers. Previous mucogingival surgery at the defect. Restorations or caries in the area to be treated and non vital tooth. Teeth which are tilted or rotated.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession

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