Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration Clinical Trial
Official title:
The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
| Verified date | July 2019 |
| Source | Islamic Azad University, Tehran |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | February 13, 2016 |
| Est. primary completion date | January 13, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 35 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 24 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 Exclusion Criteria: 1. systemic disease 2. pregnancy or breastfeeding 3. allergy drug used 4. smoking 5. medication 6. not willing to consent to participate in the study 7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Islamic Azad University, Tehran |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bone defect fill | radiographic analysis for bone defect | Three months |