NCT03204097

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

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

March 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 28, 2017

Last Update Submit

June 28, 2017

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Bone defect depth

    Assessed in percentage

    baseline, 6 & 12 months

Secondary Outcomes (5)

  • Change in modified sulcus bleeding index

    baseline, 6 & 12 months

  • Change in Plaque index

    baseline, 6 & 12 months

  • Change in pocket probing depth

    baseline, 6 & 12 months

  • Change in relative vertical clinical attachment level

    baseline, 6 & 12 months

  • Change in relative horizontal clinical attachment level

    baseline, 6 & 12 months

Study Arms (3)

group 1

PLACEBO COMPARATOR

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

Drug: placebo

group 2

ACTIVE COMPARATOR

SRP followed by 1% Alendronate (ALN) gel

Drug: Alendronate

group 3

ACTIVE COMPARATOR

SRP followed by Aloevera (AV) gel

Drug: Aloe Vera

Interventions

placeboDRUG

Oral prophylaxis followed by placement of placebo gel

Also known as: inactive drug
group 1
AlendronateDRUG

Oral prophylaxis followed by placement of Alendronate gel

Also known as: ALN
group 2
Aloe VeraDRUG

Oral prophylaxis followed by placement of Aloe Vera gel

Also known as: AV
group 3

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and HOD, Dept of Periodontology

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06