Sukhada Deo
Pune, Maharashtra, 411018, India
NCT Number: NCT03677297
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.
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Notify Me30 year–50 year
All sexes
Interventional
Phase 4
Pune, Maharashtra, 411018, India
Source from where the patients will be selected:
10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.
A detailed clinical examination, case history and written consent will be obtained from all the participants.
Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
Other names: No intervention used on Control site
Time frame: 6 months
Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect.
Difference in the measurement at the end of 6 months shows the amount of bone fill
Time frame: 6 months
Clinical parameters- Reduction in this parameter is desired at the end of 6 months
Time frame: 6 months
Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment
Time frame: 6 months
Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health
Time frame: 6 months
Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health
Dr. D. Y. Patil Dental College & Hospital
Other
Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
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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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