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

NCT07088809 · tracked via the Priya Life Science Egypt tracker
Sponsor
Enas Elgendy
Phase
Not applicable
Started
2024-10-01
Last updated
2025-07-28

Condition(s) studied

Periodontal DiseasesGingival Recession Localized ModerateNano-hydroxyapatiteNano Tricalcium PhosphatePlatelet Rich Fibrin

Investigational drug(s) / intervention(s)

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

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Enas Elgendy Tanta Gharbia Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07088809 on ClinicalTrials.gov ↗ ← All trials in Egypt