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

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ClinicalTrials.gov Identifier: NCT06016894
Recruitment Status : Completed
First Posted : August 30, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
Enas Elgendy, October 6 University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: coronally advanced flap Other: Nanocrystalline hydroxyapatite loaded in PRF Other: Nanocrystalline tricalcium phosphate loaded in PRF Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession
Actual Study Start Date : September 1, 2000
Actual Primary Completion Date : September 20, 2022
Actual Study Completion Date : April 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nanocrystalline hydroxyapatite
Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap
 Procedure: coronally advanced flap
coronally advanced flap operation

Other: Nanocrystalline hydroxyapatite loaded in PRF
Nanocrystalline hydroxyapatite loaded in PRF
Active Comparator: Nanocrystalline tricalcium phosphate (NcTCP)
Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
 Procedure: coronally advanced flap
coronally advanced flap operation

Other: Nanocrystalline tricalcium phosphate loaded in PRF
Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF


Outcome Measures
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Primary Outcome Measures :
  1. Recession height [ Time Frame: 6 months ]
    measurement recession height

  2. Recession width [ Time Frame: 6 months ]
    measurement of Recession width

  3. Height of the keratinized tissue [ Time Frame: 6 months ]
    measurement of Height of the keratinized tissue

  4. Percentage of root coverage [ Time Frame: 6 months ]
    It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.

  5. Radiographic assessment [ Time Frame: 6 months ]
    measurement of buccal bone gain


Secondary Outcome Measures :
  1. Probing pocket depth [ Time Frame: 6 months ]
    measurement of Probing pocket depth

  2. Clinical attachment level [ Time Frame: 6 months ]
    measurement of Clinical attachment level


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Enas Elgendy, Prof. of Oral Medicine and Periodontology, October 6 University
ClinicalTrials.gov Identifier: NCT06016894    
Other Study ID Numbers: khafrelsheikh university
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Gingival Recession
Periodontal Diseases
Mouth Diseases
 Stomatognathic Diseases
Gingival Diseases
Periodontal Atrophy