NCT03980847

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 23, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

May 13, 2019

Last Update Submit

June 8, 2019

Conditions

Outcome Measures

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.

    3 month

Study Arms (2)

Alendronate 20 mg with bone graft

ACTIVE COMPARATOR

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

Drug: Alendronate 20 mg

bone graft alone

ACTIVE COMPARATOR

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

Drug: Alendronate 20 mgProcedure: 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
Alendronate 20 mg with bone graftbone graft alone

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

Also known as: Group B
bone graft alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amirhossein Farahmand

Tehran, 19, Iran

Location

MeSH Terms

Conditions

Bone Resorption

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prof

Study Record Dates

First Submitted

May 13, 2019

First Posted

June 10, 2019

Study Start

February 23, 2018

Primary Completion

March 10, 2019

Study Completion

April 25, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations