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Completed

NCT Number: NCT06016894

Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF 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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

coronally advanced flap

Procedure

coronally advanced flap operation

Nanocrystalline hydroxyapatite loaded in PRF

Other

Nanocrystalline hydroxyapatite loaded in PRF

Nanocrystalline tricalcium phosphate loaded in PRF

Other

Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF

Primary outcomes

  1. Recession height

    Time frame: 6 months

    measurement recession height

  2. Recession width

    Time frame: 6 months

    measurement of Recession width

  3. Height of the keratinized tissue

    Time frame: 6 months

    measurement of Height of the keratinized tissue

  4. Percentage of root coverage

    Time frame: 6 months

    It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.

  5. Radiographic assessment

    Time frame: 6 months

    measurement of buccal bone gain

Secondary outcomes

  1. Probing pocket depth

    Time frame: 6 months

    measurement of Probing pocket depth

  2. Clinical attachment level

    Time frame: 6 months

    measurement of Clinical attachment level

Sponsors and collaborators

Lead sponsor

October 6 University

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
2000
Primary completion
2022
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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