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Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SRP and Placebo gel

SRP and Atorvastatin

SRP and Alendronate

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

Patients with a known systemic disease;
known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group;
on systemic ALN/bisphosphonate and therapy ATV/statin group;
with aggressive periodontitis;
who used tobacco in any form;
alcoholics;
immunocompromised patients;
and pregnant or lactating females were excluded from the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

Atorvastatin group

Alendronate Group

Arm Description

SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally

Outcomes

Primary Outcome Measures

Change in defect depth reduction from baseline to 6 months and from baseline to 9 months

Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval

Secondary Outcome Measures

Plaque index

Plaque index will be measured at 3, 6 and 9 months

Modified sulcus bleeding index

Modified sulcus bleeding index will be measured at 3, 6 and 9 months

Probing pocket depth

Probing pocket depth will be measured at 3, 6 and 9 months

Clinical attachment level

Clinical attachment level will be measured at 3, 6 and 9 months

Full Information

NCT ID

NCT02455869

First Posted

May 19, 2015

Last Updated

May 25, 2015

Sponsor

Government Dental College and Research Institute, Bangalore

1. Study Identification

Unique Protocol Identification Number

NCT02455869

Brief Title

Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Official Title

Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Government Dental College and Research Institute, Bangalore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed Description

Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

Arm Title

Atorvastatin group

Arm Type

Active Comparator

Arm Description

SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Arm Title

Alendronate Group

Arm Type

Active Comparator

Arm Description

Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally

Intervention Type

Drug

Intervention Name(s)

SRP and Placebo gel

Intervention Description

After SRP, placebo gel was delivered subgingivally into the pocket

Intervention Type

Drug

Intervention Name(s)

SRP and Atorvastatin

Intervention Description

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

Intervention Type

Drug

Intervention Name(s)

SRP and Alendronate

Intervention Description

After SRP, Alendronate gel was delivered subgingivally into the pocket

Primary Outcome Measure Information:

Title

Change in defect depth reduction from baseline to 6 months and from baseline to 9 months

Description

Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval

Time Frame

Baseline to 6 months and Baseline to 9 months

Secondary Outcome Measure Information:

Title

Plaque index

Description

Plaque index will be measured at 3, 6 and 9 months

Time Frame

3,6 and 9 months

Title

Modified sulcus bleeding index

Description

Modified sulcus bleeding index will be measured at 3, 6 and 9 months

Time Frame

3,6 and 9 months]

Title

Probing pocket depth

Description

Probing pocket depth will be measured at 3, 6 and 9 months

Time Frame

3,6 and 9 months]

Title

Clinical attachment level

Description

Clinical attachment level will be measured at 3, 6 and 9 months

Time Frame

3,6 and 9 months]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: Patients with a known systemic disease; known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group; on systemic ALN/bisphosphonate and therapy ATV/statin group; with aggressive periodontitis; who used tobacco in any form; alcoholics; immunocompromised patients; and pregnant or lactating females were excluded from the study

12. IPD Sharing Statement

Learn more about this trial

Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

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