Local Host Modulating Agents Alendronate & Aloe Vera for... | NCT03204097

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

NCT03204097

Sponsor

Government Dental College and Research Institute, Bangalore

Status

Completed

Last Update Posted

Jun 29, 2017Actual

Enrollment

90Actual

Phase

Phase 2Phase 3

Conditions

Chronic Periodontitis

Interventions

placebo
Alendronate
Aloe Vera

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jun 28, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2017

Last Update Posted Date

Jun 29, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. A R Pradeep, Professor and HOD, Dept of Periodontology, Government Dental College and Research Institute, BangalorePrincipal Investigator

Lead Sponsor

Government Dental College and Research Institute, BangaloreOTHER

Collaborators

Not provided

Description Module

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Oral prophylaxis followed by placement of placebo gel	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Bone defect depth	Assessed in percentage	baseline, 6 & 12 months

Secondary Outcomes

Measure	Description	Time Frame
Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 12 months
Change in Plaque index	scale 0-3	baseline, 6 & 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study -

Exclusion Criteria:Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019386	Alendronate

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided