Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

NCT03204071 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2015-2016IG
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable effect on alveolar bone. AloeVera Gel had also been used in dentistry and showed good results.The present study aims to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic periodontitis (CP) with intrabody defects.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Bone defect fill

  Assessed in percentage

  baseline - 6 months & baseline -12 months

Secondary Outcomes (4)

• 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

• Clinical attachment level

  baseline, 6 & 12 months

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.

Drug: placebo gel

Group 2

ACTIVE COMPARATOR

Aloe vera gel to be delivered at baseline, 6 and 12 months.

Drug: Aloevera

Group 3

ACTIVE COMPARATOR

1% metformin gel to be delivered at baseline, 6 and 12 months.

Drug: Metformin

Interventions

placebo gel DRUG

Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.

Also known as: inactive drug

Group 1

Aloevera DRUG

Oral prophylaxis followed by placement of aloevera gel

Also known as: AV

Group 2

Metformin DRUG

Oral prophylaxis followed by placement of metformin gel

Also known as: MF

Group 3

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months.

You may not qualify if:

• Subjects allergic to MF or AV Those on systemic MF or AV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating, and pregnant females

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic 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

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: June 29, 2017
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06