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Enrolling by Invitation

NCT Number: NCT07088809

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enas Elgendy

Tanta, Gharbia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Percentage of root coverage (RC)

    Time frame: 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%.

  2. Facial bone level

    Time frame: 6 months

    Facial bone level was the distance from the apex of the tooth to most coronal point of the facial bone.

  3. Horizontal facial bone thickness

    Time frame: after 6 months

    Horizontal facial bone thickness was the thickness of the facial bone at the middle of the root length.

  4. Recession height (RH)

    Time frame: at 1, 3 and 6 month post surgically

    distance between cemento-enamel junction (CEJ) to the most apical point of the gingival margin (GM).

  5. Recession width (RW)

    Time frame: at 1, 3 and 6 month post surgically

    from one border of the recession to another, measured at the CEJ.

  6. Height of the keratinized tissue (HKT)

    Time frame: 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).

Secondary outcomes

  1. Bone density

    Time frame: after 6 months

    Bone density: measured at the facial bone at the middle of the root length

  2. Plaque index

    Time frame: at 1, 3 and 6 month post surgically

  3. Gingival index (GI)

    Time frame: at 1, 3 and 6 month post surgically

  4. Probing pocket depth (PPD)

    Time frame: at 6 months post surgically

  5. Clinical attachment level (CAL)

    Time frame: at 6 months post surgically

  6. Wound healing index (WHI)

    Time frame: at 14 days and 1, 3, and 6 months after surgery.

Sponsors and collaborators

Lead sponsor

Enas Elgendy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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