Clincosm LogoSign in Get a demo

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

Sponsor
Islamic Azad University, Tehran (Other)
Overall Status
Completed
CT.gov ID
NCT03980847
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alendronate 20 mg
  • Procedure: Nanocrystal hydroxyapatite
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket
Actual Study Start Date :
Feb 23, 2018
Actual Primary Completion Date :
Mar 10, 2019
Actual Study Completion Date :
Apr 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Alendronate 20 mg with bone graft

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

Drug: Alendronate 20 mg
The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction
Other Names:
  • Group A

    		•
    Active Comparator: bone graft alone

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

    Drug: Alendronate 20 mg
    The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction
    Other Names:
  • Group A

    • Procedure: Nanocrystal hydroxyapatite
    Postextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft
    Other Names:
  • Group B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. New bone formation (bone area as percent) [3 month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. at least 18 years old

    2. tooth fracture, root caries

    3. Patients are volunteered for placement of teh implant

    Exclusion Criteria:

    1. systemic diseases

    2. Pregnancy and breastfeeding

    3. malignancy, radiation therapy,

    4. history of periodontal surgery during teh six months ago.

    5. medicine(phosphonates, antibiotic,...)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amirhossein Farahmand Tehran Iran, Islamic Republic of 19

    Sponsors and Collaborators

    • Islamic Azad University, Tehran

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amirhossein Farahmand, assistant prof, Islamic Azad University, Tehran
    ClinicalTrials.gov Identifier:
    NCT03980847
    Other Study ID Numbers:
    • 2036
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bone Resorption
    Alendronate

    Study Results

    No Results Posted as of Jun 11, 2019