Clinical trial NCT03677297: "Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"
Official title: Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Periodontitis
Keywords: Intervention Study
Rosuvastatin
Periodontitis
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone fill
timeFrame: 6 months
Secondary outcomes:
measure: Probing depth
timeFrame: 6 months
measure: relative attachment level
timeFrame: 6 months
measure: plaque index
timeFrame: 6 months
measure: bleeding index
timeFrame: 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Sukhada Deo
state: Maharashtra
Study officials:
affiliation: Dr. D. Y. Patil Dental College & Hospital
name: Sukhada D Deo, BDS
role: PRINCIPAL_INVESTIGATOR
References: