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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption
• Intervention / Treatment: Drug: Alendronate 20 mg; Procedure: Nanocrystal hydroxyapatite

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19
    • Amirhossein Farahmand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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,...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 month

Collaborators and Investigators

• Sponsor: Islamic Azad University, Tehran

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2018
• Primary Completion (ACTUAL): March 10, 2019
• Study Completion (ACTUAL): April 25, 2019

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (ACTUAL): June 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 8, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: 2036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No