Evaluation of the microbial load in laser micro-grooved implants of diabetic and smoker patients via a metagenomic analysis.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/08/056379
- Lead Sponsor
- SRM Dental college Ramapuram
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Systemically healthy group ( Control Group) :
1. Male or female patients with an age group of >= 30 to 60 years.
2. HbA1c levels of less than 6
3. implants placed and restored post 18 months of functional loading in a single
edentulous site which is bounded by the natural tooth on both sides primarily
in the lower posteriors (premolars and molars)..
4. Patients should be cooperative, motivated and oral hygiene conscious.
5. Presence of local factors with signs of clinical inflammation.
6. Stable occlusion with no para functional habits.
Diabetic group (Group II):
All the above-mentioned criteria shall fall the same for the Diabetic group except for the HbA1c levels.
1. Patients with HbA1c levels of 8.1 to 10 are recruited for the study ( Moderately Diabetic patients).
2. Patients who are on oral hypoglycemic drugs which do not affect the bone healing are considered for the study
3. Patients are on Diabetic care and still have higher levels of HbA1c are considered for the study.
All the above mentioned inclusion criteria for a systemically healthy patient would be considered along with patient being a current smoker
Smokers Group:
The above inclusion criteria will hold good for the same except that the patients will be Current mild smokers, i.e Patients who have smoked less than or equal to 10 Cigarettes per day and are still currently smoking at the time of implant surgery.
• Presence of active periodontal disease.
• Evidence of attachment loss greater than 1 to 2 mm
• Bone loss evaluated radiographically which is more than the middle third of the
adjacent teeth.
• Smokers
• Use of antimicrobial agents 3 months before the study.
• Patient diagnosed with known systemic diseases except type 2 Diabetic
mellitus
• Bone disorders like hyperparathyroidism, osteoporosis, or Pagetâ??s disease.
• Patients who are under steroids, anti-inflammatory and bisphosphonates in the
past 6 months.
• Patients who are treated with radiotherapy or Chemotherapeutic agents.
• Chronic alcoholics or drug abuse.
• Pregnancy and lactation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OBJECTIVES: <br/ ><br>1) To evaluate the peri-implant microbiome in Diabetics & Smokers who have received laser microgrooved implants & abutment post 18 months of functional loading. <br/ ><br>2) To compare the peri-implant microbiome in Diabetics & Smokers who have received laser microgrooved implants & abutments post 18 months of functional loading. <br/ ><br>3) To compare the peri-implant microbiome of Diabetics and smokers with healthy individuals who have received laser microgrooved implants and abutments post 18 months of functional loading. <br/ ><br>Timepoint: 18 months post functional loading
- Secondary Outcome Measures
Name Time Method SECONDARY OBJECTIVES: <br/ ><br>1) To evaluate & correlate the clinical parameters with the microbial parameters assessed among all the 3 groups post 18 months of functional loading. <br/ ><br>2) To evaluate & correlate the radiographic parameters with the microbial parameters assessed among all the 3 groups post 18 months of functional loading. <br/ ><br>3) To check for the Implant survival rate among all the three groups post 18 months of functional loading.Timepoint: 18 months post functional loading