| 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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
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Intervention / Comparator Agent
|
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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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
|
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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. |