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Evaluation of the microbial load in laser micro-grooved implants of diabetic and smoker patients via a metagenomic analysis.

Comparative assessment of microbiome in peri-implant sulcus of functionally loaded laser micro-grooved implants and abutments in smokers and patients with diabetes mellitus-A metagenomic study. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056379
Enrollment
24
Registered
2023-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Diabetics and Smokers: Supra gingival plaque will be eliminated from the implant surface using a sterile curette. After careful isolation, the sampling sites will be gently dried with a

Sponsors

SRM Dental college Ramapuram
Lead Sponsor
Dr Akanksha Singh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Systemically healthy group ( Control Group) : Inclusion criteria: 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): Inclusion criteria: 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. Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
PRIMARY OBJECTIVES: 1) To evaluate the peri-implant microbiome in Diabetics & Smokers who have received laser microgrooved implants & abutment post 18 months of functional loading. 2) To compare the peri-implant microbiome in Diabetics & Smokers who have received laser microgrooved implants & abutments post 18 months of functional loading. 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. Timepoint: 18 months post functional loading

Secondary

MeasureTime frame
SECONDARY OBJECTIVES: 1) To evaluate & correlate the clinical parameters with the microbial parameters assessed among all the 3 groups post 18 months of functional loading. 2) To evaluate & correlate the radiographic parameters with the microbial parameters assessed among all the 3 groups post 18 months of functional loading. 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

Countries

India

Contacts

Public ContactDr Akanksha Singh

SRM Dental College, Ramapuram, Tamil Nadu

akashpsg@gmail.com08095862444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026