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CompletedNCT03980847Updated Jun 11, 2019

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

A Phase 2 interventional study of Alendronate 20 mg and Nanocrystal hydroxyapatite in Bone Resorption, sponsored by Islamic Azad University, Sanandaj. Completed at 1 site in Iran. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by Islamic Azad University, Sanandaj · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Feb 2018, registered May 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Resorption

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03

In context

Bone Resorption

158 studies on the registry are indexed under Bone Resorption; 26 are open to participants now.

This study's enrollment of 20 is below the median of 24 across 137 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

Islamic Azad University, Sanandaj is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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,...)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • Active comparator
    bone graft alone

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

    Drug: Alendronate 20 mg · Procedure: Nanocrystal hydroxyapatite

Interventions

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

    Also known as: Group A

  • ProcedureNanocrystal hydroxyapatite

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

    Also known as: Group B

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 month

07

Study locations

1 site
  • Amirhossein Farahmand
    Tehran, 19, Iran
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03980847
Lead sponsor
Islamic Azad University, Sanandaj
Responsible party
Amirhossein Farahmand (assistant prof, Islamic Azad University, Sanandaj) — Principal investigator
First posted
Jun 10, 2019
Start date
Feb 23, 2018
Primary completion
Mar 10, 2019
Completion
Apr 25, 2019
Last update
Jun 11, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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