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CTRI Number  CTRI/2025/05/087456 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How special instrument affects placing implants in people with and without diabetics.  
Scientific Title of Study   Evaluation of radiological, molecular and microbiological parameters in Controlled type-II diabetic patients and non-diabetic patients using Piezosurgery at Implant site preparation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Podili Alluri Vijay Kumar 
Designation  Post Graduate Student 
Affiliation  Vishnu Dental College 
Address  Block 2, Room no.7, Department of Periodontics,Vishnupur, Bhimavaram Department Of Periodontics, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  8919165668  
Fax  08816250894  
Email  vijaykumar.pa@vdc.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr KSVRamesh 
Designation  Associate Professor 
Affiliation  Vishnu Dental College 
Address  Block 2, Room no.7, Department of Periodontics,Vishnupur, Bhimavaram Department Of Periodontics, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  8886157669  
Fax  08816250894  
Email  rameshksv@vdc.edu.in  
 
Details of Contact Person
Public Query  
Name  DrKSVRamesh 
Designation  Associate Professor 
Affiliation  Vishnu Dental College 
Address  Block 2, Room no.7, Department of Periodontics,Vishnupur, Bhimavaram Department Of Periodontics, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  8886157669  
Fax  08816250894  
Email  rameshksv@vdc.edu.in  
 
Source of Monetary or Material Support  
Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari, Andhra Pradesh, India, Postal code- 534202 
 
Primary Sponsor  
Name  Podili Alluri Vijay Kumar 
Address  Block 2, Room no.7, Department of Periodontics,Vishnupur, Bhimavaram Department Of Periodontics, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Podili Alluri Vijay Kumar  Vishnu Dental College  Block 2, Room no.7, Department of Periodontics,Vishnupur, Bhimavaram Department Of Periodontics, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India
West Godavari
ANDHRA PRADESH 		 08919165668
08816250894
vijaykumar.pa@vdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Controlled type II diabetics  Patients reporting with HbA1c between 6.6-8 will be included in intervention group as controlled type II diabetics. A mid-crestal incision will be made at the posterior maxillary edentulous region and full thickness flap will be elevated. Piezo inserts will be used to prepare the implant site, and implants with a diameter of 4.5 × 8.5 mm will be placed on which healing abutments will be placed immediately on implants exhibiting an ISQ greater than or equal to 70.Flaps will be approximated using 4-0 resorbable suture.Subgingival plaque sample without contamination of blood will be collected in vials with Tris EDTA buffer for microbial count.To avoid contamination, the selected sites will be washed with water, dried with a gentle air spray and isolated by cotton rolls.Crevicular fluid (PISF) sample will be collected during the morning hours (9AM to 11AM).Perio paper stripsTM will be placed 1–2 mm deep into the sulcus at implant site 
Comparator Agent  non diabetic patient   Patients reporting with HbA1c between less than or equal to 6.5 will be included in control group as non diabetic patient. A mid-crestal incision will be made at the posterior maxillary edentulous region and full thickness flap will be elevated. Piezo inserts will be used to prepare the implant site, and implants with a diameter of 4.5 × 8.5 mm will be placed on which healing abutments will be placed immediately on implants exhibiting an ISQ greater than or equal to 70.Flaps will be approximated using 4-0 resorbable suture.Subgingival plaque sample without contamination of blood will be collected in vials with Tris EDTA buffer for microbial count.To avoid contamination, the selected sites will be washed with water, dried with a gentle air spray and isolated by cotton rolls.Crevicular fluid (PISF) sample will be collected during the morning hours (9AM to 11AM).Perio paper stripsTM will be placed 1–2 mm deep into the sulcus at implant site 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Non-diabetic patients (HbA1c less than 6.5)
Controlled diabetic patients (HbA1c 6.5-8)(ASA I and ASA II classification)
Patients with age group till 60 years
Patients with missing maxillary posterior teeth.
Sufficient bone height (distance between bone crest and maxillary sinus greater than or equal 8 mm)
 
 
ExclusionCriteria 
Details  ASA III,IV,V.
Patient with HbA1c level greater than 8
Patients with fluctuant HbA1c levels during the study period
Patients under bone sparing treatment
Patients with parafunctional habits
Pregnant and lactating women
smokers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Radiographic outcomes- peri-implant bone changes,Mean bone density.
2.Molecular outcomes- Bone markers RANKL and OPG.
3.Microbiological count-Quantitative evaluation of porphyromonas gingivalis(Pg), tanerella forsythia(Tf), treponema denticola(Td).

 		 1.Radiographic outcomes- baseline(2 weeks) and 6 months.
2.Molecular outcomes- baseline(2 weeks),1month,3,months.
3.Microbiological count-baseline(2 weeks),1month.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Implant stability
2.Plaque index(FMPS) , Gingival index (FMGS)  		 1.Implant stability-baseline,3months.
2.Plaque index(FMPS) , Gingival index (FMGS)-baseline,1month. 
1.Implant stability
2.Plaque index(FMPS) , Gingival index (FMGS)  		 1.Implant stability-baseline,3months.
2.Plaque index(FMPS) , Gingival index (FMGS)-baseline,1month. 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   02/06/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Patients reporting to the Department of Periodontics and Implantology, Vishnu Dental College with missing maxillary posterior teeth of nondiabetic patients and controlled type II diabetic patients will be included in the study as control and test group respectively. A written informed consent will be obtained from all the patients .Implant placement will be done using Piezosurgery . Subgingival plaque and crevicular fluid sample will be collected. Implant stability, Peri implant marginal bone changes, mean bone density measured at baseline and 6months. Molecular parameters like RANKL OPG will be assessed at baseline,1month and 3 months. Microbiological parameters will be assessed at baseline and 1 month. 
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