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Completed

NCT Number: NCT03204097

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

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

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Placebo

Drug

Oral prophylaxis followed by placement of placebo gel

Other names: inactive drug

Alendronate

Drug

Oral prophylaxis followed by placement of Alendronate gel

Other names: ALN

Aloe Vera

Drug

Oral prophylaxis followed by placement of Aloe Vera gel

Other names: AV

Primary outcomes

  1. Change in Bone defect depth

    Time frame: baseline, 6 & 12 months

    Assessed in percentage

Secondary outcomes

  1. Change in modified sulcus bleeding index

    Time frame: baseline, 6 & 12 months

    scale 0-3

  2. Change in Plaque index

    Time frame: baseline, 6 & 12 months

    scale 0-3

  3. Change in pocket probing depth

    Time frame: baseline, 6 & 12 months

    measured in mm

  4. Change in relative vertical clinical attachment level

    Time frame: baseline, 6 & 12 months

    measured in mm

  5. Change in relative horizontal clinical attachment level

    Time frame: baseline, 6 & 12 months

    measured in mm

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class II Furcation Defects: A Randomized Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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