Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Test group: Moderately controlled diabetic patients receiving implants with Laser Micro-Grooved (LMG) surfaces constitute the test group.
Intervention2: Test group: Moderately controlle
Sponsors
N. Shreenidhi Utthamambigai
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients aged 30 to 60 years with HbA1c levels ranging from 8.1 to 10 are eligible for the study. Participants should be on oral hypoglycemic drugs, such as Metformin, Dipeptidyl Peptidase-4 (DPP-4) inhibitors like Sitagliptin, or Alpha-Glucosidase inhibitors like Acarbose and Miglitol, which do not interfere with bone healing. The study includes individuals with a single bounded edentulous space, primarily in the lower posteriors (premolars and molars), with intact proximal teeth and sufficient bone quantity for implant placement. Adequate bone height (at least 13mm) and bone width (at least 6mm) are required. Eligible patients must be cooperative, motivated, and maintain good oral hygiene. Additionally, participants should exhibit stable occlusion without parafunctional habits and have local factors present without signs of clinical inflammation. This study is conducted under the supervision of the Institutional Review Board of SRM Dental College, Ramapuram.
Exclusion criteria
Exclusion criteria: Patients with active periodontal disease, evidence of attachment loss greater than 1 to 2mm, or radiographic bone loss extending beyond the middle third of the adjacent teeth are excluded from the study. Additional exclusion criteria include the use of antimicrobial agents within three months before the study, a diagnosis of systemic diseases other than type 2 diabetes mellitus, and bone disorders such as hyperparathyroidism, osteoporosis, or Paget s disease. Patients who have undergone steroid therapy, anti-inflammatory treatment, or bisphosphonate use within the past six months, as well as those treated with radiotherapy or chemotherapy, are not eligible. Chronic alcoholics, smokers, and individuals with a history of drug abuse are excluded. Pregnancy and lactation are also disqualifying factors. Furthermore, patients who do not comply with the one-year follow-up requirement are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean Crestal bone level changes (mm) to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control (SLA) and Test groups (SLA-Active & LMGI). 2. Implant survival rates (%) to be assessed at 1 year with radiographic and clinical assessment between Control (SLA) and Test groups (SLA- Active & LMGI).Timepoint: Baseline and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the Relative position of gingival margin (mm) at the implant site of Control (SLA) and Test groups (SLA Active and LMGI) at Baseline, 6 months and 1 year post loading.Timepoint: baseline, 6 months and 1 year;2.To assess the Implant stability quotient (ISQ) values using resonance frequency analysis (RFA) during Early Loading protocol. 3. To assess the Early Wound Healing Index (EWHI) using Huang et al index (2005) at the 1st week, 2nd week, and 4th week during the Early Loading protocol, comparing the Control (SLA) and Test groups (SLA ACTIVE & Laser Micro-Grooved Implants).Timepoint: 1st week, 2nd week , 4th week, 6 months and 1 year | — |
Countries
India
Contacts
Public ContactN SHREENIDHI UTTHAMAMBIGAI
SRM Dental college
Outcome results
None listed