NCT07160101

Brief Summary

The aim of the study is to evaluate osseous regenerative efficacy of eggshell derived nanohydroxyapatite in comparison with hydroxyapatite The test group includes patients with intrabony defects where flap surgery will be performed \& Eggshell derived nano hydroxyapatite (ESnHA) is placed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 22, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 30, 2025

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • RVG

    Radiovisiography will be used to assess bone regeneration achieved post operatively

    3months & 6months

  • Probing Depth

    3 months & 6months

  • Clinical Attachment Level

    3 months & 6 months

Secondary Outcomes (2)

  • Full mouth Plaque index

    3 months & 6 months

  • Full mouth Gingival index

    3 months & 6 months

Study Arms (2)

Test group Eggshell derived nano hydroxyapatite

EXPERIMENTAL

In Test group after flap reflection \& degranulation, bone graft i.e Eggshell derived nano hydroxyapatite is placed into defect.

Other: Eggshell derived nano hydroxyapatite

Control group

ACTIVE COMPARATOR

In Control group, after flap reflection \& debridment bone graft i.e Hydroxyapatite is placed into defect.

Other: Hydroxyapatite

Interventions

Eggshell derived nano hydroxyapatite has high solubility and allows faster integration \& replaces with osseous tissue

Test group Eggshell derived nano hydroxyapatite

Hydroxyapatite has similar chemical composition with crystalline structure of native bone

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of Two-walled or three-walled intrabony defects \& Probing pocket depths (PPD) of \>5mm after initial therapy Systemically healthy male and female patients of age \>18 years

You may not qualify if:

  • Medically compromised patients Pregnant women, Heavy smokers, and Patients who underwent radiotherapy or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Svs Institute of Dental Sciences

Mahbūbnagar, Telangana, 509001, India

Location

MeSH Terms

Interventions

Durapatite

Intervention Hierarchy (Ancestors)

HydroxyapatitesApatitesCalcium PhosphatesPhosphatesPhosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsCalcium CompoundsMineralsPhosphorus Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFFESSOR AND HEAD OF THE DEPARTMENT

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

March 22, 2023

Primary Completion

August 13, 2024

Study Completion

March 27, 2025

Last Updated

September 15, 2025

Record last verified: 2025-08

Locations