Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes 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 "Glossary of the American of Periodontology" defines gingival recession (GR) as the apical movement of the gingival margin beyond the cement-enamel junction. Therefore, root surface exposure brought on by gingival recession results in cosmetic impairment, fear of tooth loss, increased susceptibility to root caries, and dentin hypersensitivity. 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, and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. The medical area has been invaded by nanotechnology, and the findings are highly promising. Nanomaterials perform far better than conventional materials thanks to their superior surface, size, and quantum effects. Hydroxyapatites (HAs) are a family of materials used for bone grafting that have a high level of biocompatibility, which is partly due to their inclusion in naturally calcified tissue. 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: Enrolling by invitation
• Conditions: Periodontal Diseases; Platelet Rich Fibrin; Gingival Recession Localized Moderate; Nano-hydroxyapatite; Nano Tricalcium Phosphate
• Intervention / Treatment: Procedure: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap; Procedure: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap

Detailed Description

The primary objective of periodontal therapy is the regeneration of periodontal tissues that have been lost owing to periodontal disease since gingival recession results in the loss of both soft and hard tissue. Periodontal regeneration, demonstrated histologically by the development of new cementum, new alveolar bone, functionally orientated periodontal ligament, and gingiva, is the rebuilding of the lost tissues. Platelet rich fibrin (PRF), which contains significant amounts of growth factors, platelets, fibrin membrane, leukocytes, and cytokines, was introduced for periodontal regeneration. The capacity of PRF to boost collagen production and fibroblast proliferation has been demonstrated, and it is widely used to repair and enhance the regeneration of both soft tissues and hard tissues following various periodontal surgical procedures. Xenografts were established in the field of periodontology to address the drawbacks of autogenous bone graft and allograft. Although these materials provide a solution to some of the aforementioned issues, the issue of immunogenicity and the transmission of disease had been frequently brought up; as a result, alloplastic materials were produced. These substances, which are artificial, inorganic, and biocompatible bone graft alternatives, offer a potential substitute for the treatment of periodontal disorders. The benefits of these materials include better accessibility, the removal of the requirement for a donor site, and the absence of any risk of disease transmission. In controlled clinical studies, hydroxyapatite (HA) and tricalcium phosphate (TCP), two alloplastic materials, significantly improved clinical outcomes at grafted locations compared to non-grafted sites. Cone beam computed tomography produces 3D images that are required in periodontics for the diagnosis of intra bony defects, furcation involvements, and destructions of the buccal and lingual bones. The objective of this study was to compare the effectiveness of nanocrystalline hydroxyapatite and tricalcium phosphate, both applied on a PRP membrane, in treating Miller's class 1 gingival recession in humans.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Gharbīyah
    • Tanta, Al Gharbīyah, Egypt
      • Enas Elgendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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
Experimental: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap; Ten sites with gingival recession treated with Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap.	Procedure: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap; Two horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized. Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by nanocrystale hydroxyapatite was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds.
Experimental: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap; Ten sites of gingival recession treated with Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap	Procedure: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap; Two horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized. Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by Nanocrystalline tricalcium was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of root coverage (RC)	Percentage of root coverage (RC): is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.	after 1, 3, 6 months post operatively
Facial bone level	Facial bone level was the distance from the apex of the tooth to most coronal point of the facial bone.	6 months
Horizontal facial bone thickness	Horizontal facial bone thickness was the thickness of the facial bone at the middle of the root length.	after 6 months
Recession height (RH)	distance between cemento-enamel junction (CEJ) to the most apical point of the gingival margin (GM).	at 1, 3 and 6 month post surgically
Recession width (RW)	from one border of the recession to another, measured at the CEJ.	at 1, 3 and 6 month post surgically
Height of the keratinized tissue (HKT)	Height of the keratinized tissue (HKT): distance between the most apical point of the GM and the mucogingival junction (MGJ).	1, 3 and 6 month post surgically

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Bone density: measured at the facial bone at the middle of the root length	after 6 months
Plaque index		at 1, 3 and 6 month post surgically
Gingival index (GI)		at 1, 3 and 6 month post surgically
Probing pocket depth (PPD)		at 6 months post surgically
Clinical attachment level (CAL)		at 6 months post surgically
Wound healing index (WHI)		at 14 days and 1, 3, and 6 months after surgery.

Collaborators and Investigators

• Sponsor: Enas Elgendy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 19, 2025
• First Submitted That Met QC Criteria: July 19, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: gingival recession; platelet rich plasma; nano tricalcium phosphate; nanocrystalline hydroxyapatite
• Additional Relevant MeSH Terms: Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession; Periodontal Diseases
• Other Study ID Numbers: Kafrelsheikh 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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