Table 3 List of clinical trials evaluating the effects of statins on dental and oral health (retrieved from http://www.clinicaltrials.gov)
From: The effects of statins on dental and oral health: a review of preclinical and clinical studies
| Drugsstatins | NCT identifier | Condition or diseases | Inclusion criteria | Exclusion criteria | Dose | Duration | Local/Systemic | Primary outcome | Phase | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Curcumin-Simvastatin-EDTA | NCT04044417 | Periodontitis | Patient suffering at least a single posterior 2–3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥ 3 mm, intrabony component ≥ 3 mm, plaque index ≤ 1 (Sillness and Loe, 1964) and sulcus bleeding index ≤ 1 (Mühlemann & Son, 1971), All these criteria were determined after phase I conventional periodontal therapy, Systemically healthy as evidenced by burket’s oral medicine health history question questionnaire (Glick et al. 2008) | SmokingPatient unwilling to comply with periodontal hygienic instructions. Patients under any long-term chronic medication. Vulnerable individuals | Curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin) | 6-months | Local | Probing depth (PD) | Phase 4 (Completed) |
| 2 | Atorvastatin, Simvastatin | NCT03745300 | Chronic Periodontitis Wth Diabetes Mellitus | Well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD ≥ 5 mm and CAL ≥ 3 mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy | 1) Patients with known allergy to statins; 2) Patients with systemic conditions/medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals. 8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded | Scaling and root planing (SRP) followed by 1.2% atorvastatin or 1.2% simvastatin gel local drug delivery | 6 and 9 months | Local | Change in defect depth | Phase 2 and 3 (completed) |
| 3 | Simvastatin-Methylcellulose | NCT03452891 | Periodontal Diseases | Age 40-85 years, diagnosis of chronic advanced adult periodontitis, one quadrant with at least one 6-9 mm interproximal pocket, overall good systemic health, willingness to sign consent form | Systemic diseases which significantly impact periodontal inflammation and bone turnover (e.g. rheumatoid arthritis), taking drugs which significantly impact periodontal inflammation and bone turnover (e.g. chronic use of steroids or non-steroidal anti-inflammatory drug (> 325 mg/d), estrogens, bisphosphonates, calcitonin, methotrexate), surgical periodontal therapy within the past year, pregnant or breast-feeding females | Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket | 6 and 12 months | Local | Change in Clinical Attachment Level (CAL) | Phase 4 (recruiting) |
| 4 | Rosuvastatin | NCT03677297 | Adult Periodontitis | Age group between 30–50 years, probing pocket depth ≥ 5 mm following initial therapy, suitable interproximal angular infrabony defects of ≥ 3 mm, involved teeth should be vital and asymptomatic, systemically healthy patients, Patients who demonstrate acceptable oral hygiene prior to access flap surgery. | 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 6 months, H/O osteoporosis. | 1.2% Rosuvastatin Gel. Insertion in infrabony defects once | 6 months | Local | Bone fill | Phase 4 (completed) |
| 5 | Simvastatin | NCT03419429 | Chronic Periodontitis | Patients were all healthy and free from any systemic disease, No history of antibiotic therapy or periodontal treatment for at least six months preceding the study, Patients were willing and able to return for multiple follow up visits, Periodontal defects with Probing depth > 5 mm, Clinical attachment loss > 4 mm, Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph, Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one) | Pregnancy, lactation for female patients, smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines, history of allergic reaction to the medications used, vulnerable groups and handicapped | Open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane | 9 months | Local | Probing pocket depth | Phase 4 (Completed) |
| 6 | SRP plus Rosuvastatin gel | NCT03043196 | Chronic Periodontitis | Systemically healthy CP subjects aged between 30 and 50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3 mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥ 5 mm or CAL ≥ 3 mm in an asymptomatic tooth were included in the study, a subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years | Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study | Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects | 9 months | Local | Defect depth reduction | Phase 2 and 3 (completed) |
| 7 | Lovastatin gel | NCT03178526 | Alveolar Bone Loss, Chronic Periodontitis | Patients with 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 | Systemic disease, pregnancy or breastfeeding, allergy drug used, smoking, medication, 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 | Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe | 3 months | Local | Bone defect fill | Phase 2 and 3 (completed) |
