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CTRI Number  CTRI/2025/04/084998 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Replacement of tooth using implants in diabetic patients. 
Scientific Title of Study   Comparative evaluation of crestal bone level changes between SLA, SLA ACTIVE and LASER MICROGROOVED dental implants using minimally invasive flapless technique in diabetic individuals- A randomized controlled clinical trial 
Trial Acronym  SALI-D 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  N SHREENIDHI UTTHAMAMBIGAI  
Designation  First year post graduate student  
Affiliation  SRM Dental college  
Address  Department of periodontology, SRM Dental college, Bharathi salai, Ramapuram, chennai

Chennai
TAMIL NADU
600089
India 
Phone  9962216826  
Fax    
Email  u.n.srinidhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PSG PRAKASH 
Designation  PROFESSOR  
Affiliation  SRM Dental college  
Address  Department of periodontology, SRM Dental college, Bharathi salai, Ramapuram, Chennai

Chennai
TAMIL NADU
600089
India 
Phone  9840870990  
Fax    
Email  prakashp@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  N SHREENIDHI UTTHAMAMBIGAI 
Designation  MDS PERIODONTICS 
Affiliation  SRM Dental college 
Address  Department of periodontology, SRM Dental college, Bharathi salai, Ramapuram, Chennai

Chennai
TAMIL NADU
600089
India 
Phone  09962216826  
Fax    
Email  u.n.srinidhi@gmail.com  
 
Source of Monetary or Material Support  
3rd floor, Department of periodontology, SRM Dental college, Bharathi salai, Ramapuram, Chennai-89 
 
Primary Sponsor  
Name  N. Shreenidhi Utthamambigai 
Address  D5&D6, AGS Colony phase3, Kaveri street, Mansarovar avenue, Mugalivakkam, Chennai 600125 
Type of Sponsor  Other [SELF FUNDED] 
 
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 
PSG PRAKASH  SRM DENTAL COLLEGE, RAMAPURAM  Department of periodontology, SRM Dental college, Bharathi salai, Ramapuram, chennai
Chennai
TAMIL NADU 		 9840870990

prakashp@srm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Moderately controlled diabetic patients receiving implants with sand blasted large grid acid etched implants- Neoporous surface(SLA) surfaces constitute the control group. 
Intervention  Test group  Moderately controlled diabetic patients receiving implants with Laser Micro-Grooved (LMG) surfaces constitute the test group. 
Intervention  Test group  Moderately controlled diabetic patients receiving implants with sand blasted large grid acid etched Active implants(SLA Active)- Neoaqua surface surfaces constitute the test group. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Male or female patients aged 30 to 60 years with HbA1c levels ranging from 8.1 to 10 are eligible for the study. Participants should be on oral hypoglycemic drugs, such as Metformin, Dipeptidyl Peptidase-4 (DPP-4) inhibitors like Sitagliptin, or Alpha-Glucosidase inhibitors like Acarbose and Miglitol, which do not interfere with bone healing. The study includes individuals with a single bounded edentulous space, primarily in the lower posteriors (premolars and molars), with intact proximal teeth and sufficient bone quantity for implant placement. Adequate bone height (at least 13mm) and bone width (at least 6mm) are required. Eligible patients must be cooperative, motivated, and maintain good oral hygiene. Additionally, participants should exhibit stable occlusion without parafunctional habits and have local factors present without signs of clinical inflammation. This study is conducted under the supervision of the Institutional Review Board of SRM Dental College, Ramapuram. 
 
ExclusionCriteria 
Details  Patients with active periodontal disease, evidence of attachment loss greater than 1 to 2mm, or radiographic bone loss extending beyond the middle third of the adjacent teeth are excluded from the study. Additional exclusion criteria include the use of antimicrobial agents within three months before the study, a diagnosis of systemic diseases other than type 2 diabetes mellitus, and bone disorders such as hyperparathyroidism, osteoporosis, or Paget’s disease. Patients who have undergone steroid therapy, anti-inflammatory treatment, or bisphosphonate use within the past six months, as well as those treated with radiotherapy or chemotherapy, are not eligible. Chronic alcoholics, smokers, and individuals with a history of drug abuse are excluded. Pregnancy and lactation are also disqualifying factors. Furthermore, patients who do not comply with the one-year follow-up requirement are excluded from the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Mean Crestal bone level changes (mm) to be assessed at Baseline
and 1 year with standardized Intra oral periapical radiographs in Control
(SLA) and Test groups (SLA-Active & LMGI).
2. Implant survival rates (%) to be assessed at 1 year with radiographic

and clinical assessment between Control (SLA) and Test groups (SLA-
Active & LMGI). 		 Baseline and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the Relative position of gingival margin (mm) at the implant site of Control (SLA) and Test groups (SLA Active and LMGI) at Baseline, 6 months and 1 year post loading.  baseline, 6 months and 1 year 
2.To assess the Implant stability quotient (ISQ) values using resonance frequency analysis (RFA) during Early Loading protocol.
3. To assess the Early Wound Healing Index (EWHI) using Huang et al index (2005) at the 1st week, 2nd week, and 4th week during the Early Loading protocol, comparing the Control (SLA) and Test groups (SLA ACTIVE & Laser Micro-Grooved Implants). 		 1st week, 2nd week , 4th week, 6 months and 1 year 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/05/2025 
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="2"
Months="0"
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   This study evaluates how microgeometrical surface modifications of dental implants impact stability, crestal bone preservation, peri-implant health, and implant survival, particularly in diabetic individuals. The findings will provide insights to optimize implant selection, treatment planning, and patient care, contributing to improved long-term success and patient outcomes. 
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