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NCT Number: NCT03677297

"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"

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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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sukhada Deo

Pune, Maharashtra, 411018, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age group between 30-50 years
  • Probing pocket depth ≥ 5mm following initial therapy.
  • Suitable interproximal angular infrabony defects of ≥3mm.
  • Involved teeth should be vital and asymptomatic.
  • Systemically healthy patients.
  • Patients who demonstrate acceptable oral hygiene prior to access flap surgery.
  • Patients agreed to sign informed consent and willing to return for the follow up visits.

Exclusion criteria

  • Systemic statin therapy
  • Known or suspected allergy to the statin group
  • Allergy to sulfur containing drugs
  • History of aggressive periodontitis.
  • Presence of gingival recession at the surgical site.
  • Mobility of study teeth ≥ grade I.
  • Use of tobacco in any form.
  • Pregnant and lactating women.
  • patients who have received any anti-inflammatory drugs and antibiotics in the previous six months.
  • H/O osteoporosis.

Treatment and study plan

Rosuvastatin

Drug

Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel

Other names: No intervention used on Control site

Primary outcomes

  1. Bone fill

    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

Secondary outcomes

  1. Probing depth

    Time frame: 6 months

    Clinical parameters- Reduction in this parameter is desired at the end of 6 months

  2. relative attachment level

    Time frame: 6 months

    Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment

  3. plaque index

    Time frame: 6 months

    Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health

  4. bleeding index

    Time frame: 6 months

    Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health

Sponsors and collaborators

Lead sponsor

Dr. D. Y. Patil Dental College & Hospital

Other

Registry information

Official study title

Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2018
Registry last updated
Sep 19, 2018

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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