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Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis

NCT ID: NCT03204097

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-28

Brief Summary

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Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects

Detailed Description

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Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. Then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 1

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral prophylaxis followed by placement of placebo gel

group 2

SRP followed by 1% Alendronate (ALN) gel

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

Oral prophylaxis followed by placement of Alendronate gel

group 3

SRP followed by Aloevera (AV) gel

Group Type ACTIVE_COMPARATOR

Aloe Vera

Intervention Type DRUG

Oral prophylaxis followed by placement of Aloe Vera gel

Interventions

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placebo

Oral prophylaxis followed by placement of placebo gel

Intervention Type DRUG

Alendronate

Oral prophylaxis followed by placement of Alendronate gel

Intervention Type DRUG

Aloe Vera

Oral prophylaxis followed by placement of Aloe Vera gel

Intervention Type DRUG

Other Intervention Names

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inactive drug ALN AV

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor and HOD, Dept of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GDCRI/ACM/PG/PhD/2/2015-2016IP

Identifier Type: -

Identifier Source: org_study_id