NCT06016894

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
22.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

22.1 years

First QC Date

August 24, 2023

Last Update Submit

August 24, 2023

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (5)

  • Recession height

    measurement recession height

    6 months

  • Recession width

    measurement of Recession width

    6 months

  • Height of the keratinized tissue

    measurement of Height of the keratinized tissue

    6 months

  • Percentage of root coverage

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

    6 months

  • Radiographic assessment

    measurement of buccal bone gain

    6 months

Secondary Outcomes (2)

  • Probing pocket depth

    6 months

  • Clinical attachment level

    6 months

Study Arms (2)

Nanocrystalline hydroxyapatite

ACTIVE COMPARATOR

Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

Procedure: coronally advanced flapOther: Nanocrystalline hydroxyapatite loaded in PRF

Nanocrystalline tricalcium phosphate (NcTCP)

ACTIVE COMPARATOR

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

Procedure: coronally advanced flapOther: Nanocrystalline tricalcium phosphate loaded in PRF

Interventions

coronally advanced flapPROCEDURE

coronally advanced flap operation

Nanocrystalline hydroxyapatiteNanocrystalline tricalcium phosphate (NcTCP)
Nanocrystalline hydroxyapatite loaded in PRFOTHER

Nanocrystalline hydroxyapatite loaded in PRF

Nanocrystalline hydroxyapatite
Nanocrystalline tricalcium phosphate loaded in PRFOTHER

Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF

Nanocrystalline tricalcium phosphate (NcTCP)

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

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
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Oral Medicine and Periodontology

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

September 1, 2000

Primary Completion

September 20, 2022

Study Completion

April 22, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share