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

NCT07088809 | Enrolling By Invitation

• 1 other identifier: Kafrelsheikh 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Gingival Recession Localized Moderate; Nano-hydroxyapatite; Nano Tricalcium Phosphate; Platelet Rich Fibrin

Keywords

gingival recession; nano tricalcium phosphate; nanocrystalline hydroxyapatite; platelet rich plasma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Bone density

  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

Study Arms (2)

Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

EXPERIMENTAL

Ten sites with gingival recession treated with Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap.

Procedure: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

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

EXPERIMENTAL

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

Interventions

Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap PROCEDURE

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.

Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

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

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.

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enas Elgendy: lead

Study Sites (1)

Enas Elgendy

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingival Recession

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof of Oral Medicine and Periodontology

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)