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

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ClinicalTrials.gov Identifier: NCT03204097
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: placebo Drug: Alendronate Drug: Aloe Vera Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class II Furcation Defects: A Randomized Controlled Clinical Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: placebo
Oral prophylaxis followed by placement of placebo gel
Other Name: inactive drug

Active Comparator: group 2
SRP followed by 1% Alendronate (ALN) gel
Drug: Alendronate
Oral prophylaxis followed by placement of Alendronate gel
Other Name: ALN

Active Comparator: group 3
SRP followed by Aloevera (AV) gel
Drug: Aloe Vera
Oral prophylaxis followed by placement of Aloe Vera gel
Other Name: AV




Primary Outcome Measures :
  1. Change in Bone defect depth [ Time Frame: baseline, 6 & 12 months ]
    Assessed in percentage


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Dr. A R Pradeep, Professor and HOD, Dept of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT03204097     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2015-2016IP
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Furcation Defects
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs