Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

NCT02455869 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014J
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 6 months and Baseline to 9 months

Secondary Outcomes (4)

• Plaque index

  3,6 and 9 months

• Modified sulcus bleeding index

  3,6 and 9 months]

• Probing pocket depth

  3,6 and 9 months]

• Clinical attachment level

  3,6 and 9 months]

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Drug: SRP and Placebo gel

Atorvastatin group

ACTIVE COMPARATOR

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

Drug: SRP and Atorvastatin

Alendronate Group

ACTIVE COMPARATOR

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

Drug: SRP and Alendronate

Interventions

SRP and Placebo gel DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Placebo group

SRP and Atorvastatin DRUG

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

Atorvastatin group

SRP and Alendronate DRUG

After SRP, Alendronate gel was delivered subgingivally into the pocket

Alendronate Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Atorvastatin; Alendronate

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 28, 2015
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05