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

Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: coronally advanced flap; Other: Nanocrystalline hydroxyapatite loaded in PRF; Other: Nanocrystalline tricalcium phosphate loaded in PRF

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	measurement of Probing pocket depth	6 months
Clinical attachment level	measurement of Clinical attachment level	6 months

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2000
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): April 22, 2023

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Periodontitis; Gingival Recession
• Other Study ID Numbers: khafrelsheikh university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No