Replacement of tooth using implants in diabetic patients.

Not yet recruiting

Brief Summary: This study evaluates how microgeometrical surface modifications of dental implants impact stability, crestal bone preservation, peri-implant health, and implant survival, particularly in diabetic individuals. The findings will provide insights to optimize implant selection, treatment planning, and patient care, contributing to improved long-term success and patient outcomes.

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
and 1 year with standardized Intra oral periapical radiographs in Control	Baseline and 1 year
(SLA) and Test groups (SLA-Active & LMGI).	Baseline and 1 year
2. Implant survival rates (%) to be assessed at 1 year with radiographic	Baseline and 1 year
Active & LMGI).	Baseline and 1 year
1.Mean Crestal bone level changes (mm) to be assessed at Baseline	Baseline and 1 year
and clinical assessment between Control (SLA) and Test groups (SLA-	Baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
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.	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).

Locations (1): SRM DENTAL COLLEGE, RAMAPURAM
🇮🇳
Chennai, TAMIL NADU, India
SRM DENTAL COLLEGE, RAMAPURAM
🇮🇳Chennai, TAMIL NADU, India
PSG PRAKASH
Principal investigator
9840870990
prakashp@srm.edu.in