Health Condition 1: K054- Periodontosis
Conditions
Interventions
Intervention1: Single Dose Fixed Dose Combination (FDC) of Doxycycline Hyclate and Metformin Hydrochloride gel (Prototype 1): Single Dose Prototype 2 Fixed Dose Combination (FDC) of Doxycycline Hycla
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 18 – 65 years of age (Both inclusive), with a clinical diagnosis of Stage III or stage IV periodontitis characterized by =5 mm interdental clinical attachment loss (CAL) and pockets measured with probing depth (PD) =6 mm. 2. Subjects with =14 natural teeth. 3. Willing to provide written informed consent and comply with study instructions for its duration. 4. In good general health other than periodontitis according to medical history, physical examination and clinical judgment undertaken by investigator. 5. Non-alcoholics & Non-smokers / Ex-smokers (at least 2years of abstinence) 6. Able to follow written and verbal instructions, perform oral hygiene as specified in the protocol, & return to the center for specified study visits. 7. Negative serum pregnancy test prior to beginning therapy and agreement to use adequate birth control during the study for females of child-bearing potential.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Doxycycline Hyclate or other Tetracyclines and/or Metformin/Biguanide group or any excipients or any related drug or any substance. 2. Compromised renal function (as indicated by serum creatinine levels > 1.5 times ULN) 3. Ongoing systemic cancer chemotherapy and/or radiation therapy. 4. Known history or presence of tobacco chewing and / or betel nut usage. 5. Known history or presence of clinically significant acute or chronic illness such as Diabetes Mellitus, Neutropenia (Severe and/or acquired), Inflammatory Bowel Disease (IBD), Osteoporosis, Hyperparathyroidism, Oral candidiasis, Rheumatic fever, Cancer, Connective tissue disease (such as Systemic Lupus Erythematosus (SLE), Lichen Planus, Rheumatoid Arthritis (RA), Systemic sclerosis (scleroderma) and Ankylosing Spondylitis) etc., 6. Presence of clinically significant cardiovascular, Hepatic, Pulmonary, Neurologic, Renal or Psychiatric disorder, or clinically significant laboratory abnormalities as judged by investigator 7. A positive hepatitis screen including positive test result for hepatitis B surface antigen and/or HCV antibodies & HIV antibody (I & II). 8. Prior/Ongoing treatment with the following medications: Mouthwash with known antibacterial properties (regularly within 1 month prior to baseline examination) ? Antimicrobials (6 weeks prior to baseline examination) ? Sulfasalazine and/or drugs causing gingival hyperplasia such as Phenytoin and other anticonvulsants (Phenobarbital, Lamotrigine, Vigabatrin, Ethosuximide, Topiramate and Primidone) or Cyclosporine or Calcium Channel Blockers (CCB) such as Nifedipine, Amlodipine, and Verapamil) (within 3 months prior to baseline examination) ? Systemic, topical application inside oral cavity & inhalational corticosteroids or Oral Bisphosphonates (6 months prior to baseline examination) ? Patients on systemic metformin therapy 9. Any need for systemic or local antibiotic prophylaxis prior to enrollment (e.g., for recent orthopedic implants, Patients with a prosthetic heart valve etc.,) 10. Ongoing pregnancy, lactation or plan of pregnancy during the proposed study period or not using an acceptable method of birth control (IUD, Norplant, Depo-Provera, Diaphragm, or Condom). 11. Enrolled in any other investigational medication study currently, or within the last 6 months. 12. Investigators opinion that subject is not suitable for the study otherwise. 13. Periodontitis disease specific exclusion criteria: a. Accumulation of substantial sub-gingival calculus defined as 80% or greater surfaces of the dentition having dental calculus. (Process of assessing this will be explained in separate study specific dental assessment manual) b. Undergone ? SRP (Scaling and Root Planning) therapy (less than 6 months prior to base line examination) ? Surgical periodontal treatment (within past 6 months or scheduled during the study) or ? Orthodontic therapy including removable partial denture (ongoing or scheduled during the study) c. Requirement of restorative and endodontic therapy during the study period d. Periodontal sites with Class III furcation e. CAL is only due to local factor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in clinical attachment loss (CAL)Timepoint: Day 0 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of self-completed Oral Health Impact Profile (OHIP) -14 questionnaire from BaselineTimepoint: Day 0 and Day 90;Change in Modified Papillary Bleeding Index (MPBI) from BaselineTimepoint: Day 0, Day 28, Day 60, Day 90;Change in New Method of Plaque Scoring (NMPS) from BaselineTimepoint: Day 0, Day 28, Day 60, Day 90;Exploratory Endpoint : Percentage change in Intra Bony Defect (IBD) / Radiographic Bone Loss (RBL)Timepoint: Day 0 and Day 90;Exploratory Endpoint :To evaluate release profile of Doxycycline (In GCF & In saliva) and Metformin (In GCF) with each prototype (T1 & T2) in 12 subjects in each arm to assess.Timepoint: GCF and Saliva Collection will be done at pre-dose to 168/192 hours ;Mean Change in clinical attachment loss (CAL)Timepoint: Day 0, Day 28, Day 60;Mean Change in probing depth (PD)Timepoint: Day 0, Day 28, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactVipul Modh
Dr. Reddy’s Laboratories Limited
Outcome results
None listed