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Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket

Primary Purpose

Bone Resorption

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Alendronate 20 mg

Nanocrystal hydroxyapatite

About this trial

This is an interventional treatment trial for Bone Resorption

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

at least 18 years old
tooth fracture, root caries
Patients are volunteered for placement of teh implant

Exclusion Criteria:

systemic diseases
Pregnancy and breastfeeding
malignancy, radiation therapy,
history of periodontal surgery during teh six months ago.
medicine(phosphonates, antibiotic,...)

Sites / Locations

Amirhossein Farahmand

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Alendronate 20 mg with bone graft

bone graft alone

Arm Description

after tooth extraction, put teh Alendronate 20mg with bone graft within teh tooth socket

after tooth extraction, put the bone graft within the tooth socket

Outcomes

Primary Outcome Measures

New bone formation (bone area as percent)

Combination Lovastatin produced increased vital bone more percentage compared to the nanocrystal bone graft alone group. The new bone formation and alveolar ridge preservation with bone graft after extraction of pre-molar teeth could result in the maintenance of sufficient bone volume to place an implant in an ideal restorative position without the need for auxiliary implant site development procedures.

Secondary Outcome Measures

Full Information

NCT ID

NCT03980847

First Posted

May 13, 2019

Last Updated

June 8, 2019

Sponsor

Islamic Azad University, Tehran

1. Study Identification

Unique Protocol Identification Number

NCT03980847

Brief Title

Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket

Official Title

Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

February 23, 2018 (Actual)

Primary Completion Date

March 10, 2019 (Actual)

Study Completion Date

April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Islamic Azad University, Tehran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in teh research project, which TEMPhas more TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or Fractures were selected.

Detailed Description

20 healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. Furthermore, divided the socket randomly to two groups(A, B)including A: bone graft wif Alendronate and B: bone graft alone, after 3 months wif trephine will collect the samples. following the histomorphometric analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Resorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alendronate 20 mg with bone graft

Arm Type

Active Comparator

Arm Description

after tooth extraction, put teh Alendronate 20mg with bone graft within teh tooth socket

Arm Title

bone graft alone

Arm Type

Active Comparator

Arm Description

after tooth extraction, put the bone graft within the tooth socket

Intervention Type

Drug

Intervention Name(s)

Alendronate 20 mg

Other Intervention Name(s)

Group A

Intervention Description

The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction

Intervention Type

Procedure

Intervention Name(s)

Nanocrystal hydroxyapatite

Other Intervention Name(s)

Group B

Intervention Description

Postextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft

Primary Outcome Measure Information:

Title

New bone formation (bone area as percent)

Description

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: at least 18 years old tooth fracture, root caries Patients are volunteered for placement of teh implant Exclusion Criteria: systemic diseases Pregnancy and breastfeeding malignancy, radiation therapy, history of periodontal surgery during teh six months ago. medicine(phosphonates, antibiotic,...)

Facility Information:

Facility Name

Amirhossein Farahmand

City

Tehran

ZIP/Postal Code

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket

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