NCT05100615

Brief Summary

recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

September 28, 2021

Last Update Submit

October 20, 2021

Conditions

Effects of the Elements

Outcome Measures

Primary Outcomes (1)

  • healing of periapical lesion

    change in size of bony defect

    interappointment at 1 month, 3 months and 6 months

Study Arms (3)

hydroxyappatite

OTHER

hydroxyapatite powder used for enhancement of bone regeneration

Procedure: surgery

nanohydroxyapatite

OTHER

nanohydroxyapatite powder used for enhancement of bone regeneration

Procedure: surgery

PRF with nanohydroxyapatite

OTHER

platelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration

Procedure: surgery

Interventions

surgeryPROCEDURE

applying the graft inside bony defect after surgery

PRF with nanohydroxyapatitehydroxyappatitenanohydroxyapatite

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.

You may not qualify if:

  • Any systemic debilitating disease such as:
  • Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira mohammed fathy Elkholly

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Amira Elkholly, PHD

CONTACT

+201001902507dr.amiraelkholly@yahoo.com

Reham Hassan, Ass.prof

CONTACT

+201001542529reham-hassan@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD student- Endodontic Departement

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 29, 2021

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations

EG(1)