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

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

Tracking Information

• First Submitted Date: August 24, 2023
• First Posted Date: August 30, 2023
• Last Update Posted Date: August 30, 2023
• Actual Study Start Date: September 1, 2000
• Actual Primary Completion Date: September 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2023)

• Recession height [ Time Frame: 6 months ]
  measurement recession height
• Recession width [ Time Frame: 6 months ]
  measurement of Recession width
• Height of the keratinized tissue [ Time Frame: 6 months ]
  measurement of Height of the keratinized tissue
• 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%.
• Radiographic assessment [ Time Frame: 6 months ]
  measurement of buccal bone gain

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 24, 2023)

• Probing pocket depth [ Time Frame: 6 months ]
  measurement of Probing pocket depth
• Clinical attachment level [ Time Frame: 6 months ]
  measurement of Clinical attachment level

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Periodontitis

Intervention

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

Study Arms

• Active Comparator: Nanocrystalline hydroxyapatite
  Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap
  Interventions:

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

  • Procedure: coronally advanced flap
  • Other: Nanocrystalline tricalcium phosphate loaded in PRF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2023): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 22, 2023
• Actual Primary Completion Date: September 20, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06016894
• Other Study ID Numbers: khafrelsheikh university
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Enas Elgendy, October 6 University
• Original Responsible Party: Same as current
• Current Study Sponsor: October 6 University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: October 6 University
• Verification Date: August 2023