The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

NCT03178526 | Completed Phase 2 DMC

• 1 other identifier: 25187
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis. Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study. Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P\<0.05) was considered significant.

Conditions

Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

Outcome Measures

Primary Outcomes (1)

• Bone defect fill

  radiographic analysis for bone defect

  Three months

Study Arms (2)

levostatin gel

ACTIVE COMPARATOR

levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe

Drug: Lovastatin gel

placebo gel

PLACEBO COMPARATOR

placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe

Drug: Placebo

Interventions

Lovastatin gel DRUG

Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe

Also known as: Group A

levostatin gel

Placebo DRUG

placebo gel

placebo gel

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected

You may not qualify if:

• systemic disease
• pregnancy or breastfeeding
• allergy drug used
• smoking
• medication 6. not willing to consent to participate in the study
• Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

MeSH Terms

Conditions

Alveolar Bone Loss; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The effect of lovastatin gel in the treatment of chronic periodontitis a randomized controlled trial with split-mouth

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: December 24, 2015
• Primary Completion: January 13, 2016
• Study Completion: February 13, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share