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CTRI Number  CTRI/2023/08/056379 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 08/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of the microbial load in laser micro-grooved implants of diabetic and smoker patients via a metagenomic analysis. 
Scientific Title of Study   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. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akanksha Singh 
Designation  PG Student 
Affiliation  SRM Dental College, Ramapuram, Tamil Nadu 
Address  Department of Periodontics and oral Implantology, SRM Dental College , Ramapuram , chennai-89
bharathi salai, ramapuram , Chennai-89
Kancheepuram
TAMIL NADU
600089
India 
Phone  08095862444  
Fax    
Email  singh.akanksha9510@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PSG Prakash 
Designation  Professor 
Affiliation  SRM Dental College, Ramapuram, Tamil Nadu 
Address  Department of Periodontology and oral implantology, SRM Dental college,Ramapuram
bharathi salai, ramapuram , Chennai-89
Kancheepuram
TAMIL NADU
600089
India 
Phone  08095862444  
Fax    
Email  akashpsg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akanksha Singh 
Designation  PG Student 
Affiliation  SRM Dental College, Ramapuram, Tamil Nadu 
Address  SRM Dental college, Ramapuram, Bharathi salai- chennai-89
bharathi salai, ramapuram , Chennai-89
Kancheepuram
TAMIL NADU
600089
India 
Phone  08095862444  
Fax    
Email  singh.akanksha9510@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Oral Implantology,SRM Dental College, Ramapuram 
 
Primary Sponsor  
Name  SRM Dental college Ramapuram 
Address  Bharthi Salai , Chennai-89 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Dr Akanksha Singh  SRM Dental college, Ramapuram 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akanksha Singh  SRM Dental College  Department of Periodontics and oral implantology, Department number 4, third floor, srm dental college , ramapuram,Bharthi Salai, Chennai-89
Kancheepuram
TAMIL NADU 
8095862444

singh.akanksha9510@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Dental College- Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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 Paget’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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.
 
18 months post functional loading 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
18 months post functional loading 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Bacterial colonization of dental implants may be followed by chronic inflammation of peri-implant hard and soft tissues. Several studies have demonstrated that the long-term prognosis of osseointegrated implants depends on the biofilm mass and the colonizing species within the biofilm which can in-turn influence Early crestal bone loss . (Kolenbrander PE et al 2000).

The early processes of supra- and subgingival biofilm formation, such as the generation of an acquired pellicle from salivary biopolymers or enzymes and the adherence of early colonizing microorganisms, have been described together with the relationship between biofilm formation and periodontitis or peri-implantitis respectively ( Heuer W et al 2007). For example, Streptococcus or Actinomyces species are known to create the preconditions for the accumulation of Gram-negative anaerobic late-colonizing microorganisms, such as Fusobacterium or Prevotella species . These bacteria, as well as Aggregatibacter actinomycetemcomitans or Porphyromonas gingivalis, have been frequently isolated from diseased periodontal or peri-implant sites and have been designated as highly relevant for the development of chronic periodontal or peri-implant inflammatory processes.

Several studies have shown that the microbial composition shifts toward a higher proportion of periodontal pathogens during peri-implant biofilm formation. This shift, as well as the general process of biofilm formation, is affected by various factors like ecological cofactors like pocket formation, salivary composition, and nutrition and patients systemic conditions like Diabetes (Oliveira et al PG 2020) and habits like smoking (Kasat V et al 2012). The contribution of different implant design characteristics (Sathya Ramanathan et al 2020) to the accumulation of biofilms and the following clinical consequences are also discussed as one of the major influencer. (Heuer W et al 2012).

Taking into consideration that smoking and Diabetics were previously considered as

risk factors for implant failure

and also a known modifier of periodontal and peri- implant microflora qualitatively and quantitatively which can endanger the success of

dental implants causing peri-implantitis and leading to Greater Crestal Bone loss. 

NOVELTY OF THE STUDY : The proposed implant design (Laser microgrooved implants and the abutments) by itself is novel and less researched. The major criteria assessed for implants are their success rate and the crestal bone level changes post 1 year of functional loading. As implants have gained greater success rate it is the crestal bone level changes that still needs attention as most of the implant systems have early crestal bone loss due to the micro gap present between the implant and the abutment junction leading to microbial colonisation. The proposed implant design is supposed to have micro-grooving on implant collar and abutment junction which gives us a ‘cold welding” effect and reduces microgap and supposed to reduce microbial load and thereby reducing mean crestal bone loss (Sathya et al 2020). Previously the microflora of periodontal disease and peri-implantitis was considered to be the same but off late they have seen a shift in the microbial colonisation and as the full microbiome of the peri-implant sulcus sites are not evaluated much to find the significant difference so the metagenomic sequencing (Kumar et al) would help us to evaluate the same. The main important risk factors which are considered other than bacterial challenge is systemic and environmental factors thus addressing them giving this implant system would benefit the patients as a whole. Thus this study gets the novelty that it is the first to address the microbiome of diabetics, smokers and systemically healthy patients who have received laser micro-grooved implants and abutments which could address the reduction in mean crestal bone levels. 

 
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