NCT03981601

Brief Summary

Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which have 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
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
unknown

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 22, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

February 9, 2019

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Socket preservation with Lovastatin as evaluated by the amount of bone formation volume

    3 month

Study Arms (2)

lovastatin 40 mg with bone graft

ACTIVE COMPARATOR

after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket

Drug: Lovastatin 40 MG

without drug with bone graft

ACTIVE COMPARATOR

after tooth extraction, put the bone graft wifin tooth socket

Procedure: without drug with Bone graft

Interventions

after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket

Also known as: Group A
lovastatin 40 mg with bone graft

after tooth extraction, put teh bone graft wifin tooth socket

Also known as: Group B
without drug with bone graft

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 the implant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amirhossein Farahmand

Tehran, 19, Iran

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

LovastatinPharmaceutical PreparationsBone Transplantation

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Central Study Contacts

Amirhossein Farahmand, Assistant Prof

CONTACT

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

February 9, 2019

First Posted

June 11, 2019

Study Start

February 22, 2018

Primary Completion

March 30, 2019

Study Completion

July 30, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations