FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087428 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Efficacy of Plasma Activated Dental Implants in Individuals with Vitamin D Deficiency/Insufficiency - A Randomized Controlled Clinical Trial  
Scientific Title of Study   Clinical Efficacy of Plasma Activated Dental Implants in Individuals with Vitamin D Deficiency/Insufficiency - A Randomized Controlled Clinical Trial  
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 Arvinda Siva J 
Designation  I yr Post Graduate, Dept of Periodontology, Room No:5 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of periodontology, Room no:5, Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone  7550191145  
Fax    
Email  d0624003@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vamsi Lavu 
Designation  Professor, Dept of Periodontology, Room No:5 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9841326869  
Fax    
Email  vamsilavu@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Arvinda Siva J 
Designation  I yr Post Graduate, Dept of Periodontology, Room No:5 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Dept of Periodontology, Room No:5, Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone  7550191145  
Fax    
Email  d0624003@sriher.edu.in  
 
Source of Monetary or Material Support  
Dr. Arvinda Siva J , I yr Post Graduate, Dept of periodontology, Room No:5, Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur, Chennai-600116 
 
Primary Sponsor  
Name  Dr Arvinda Siva J 
Address  Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur, Chennai-600116 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Self  Chennai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvinda Siva J  Sri Ramachandra Dental College and Hospital  Department of Periodontology, Room no: 5, Sri Ramachandra Dental College and Hospitals, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU 
7550191145

d0624003@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Students Project   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Vitamin D Deficiency/Insufficiency  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dental Implant Placement   Conventional (No Activation) Dental Implants in individuals with Vitamin D deficiency/ insufficiency Duration: Years: 1 Months:6 (August 2025 to January 2027) 
Intervention  Dental Implant Placement  Plasma Activated Dental Implants in individuals with Vitamin D deficiency/ insufficiency Duration of intervention : Years: 1 Months:6 (August 2025 to January 2027) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Systemically healthy individuals between 20- 45 years of age
Both gender- male and female.
Vitamin D deficient less than 20 ng per ml or Insufficient 20-29 ng per ml (as per ICMR guidelines)
Partially edentulous with minimum of one missing tooth in either maxillary or mandibular arches
Adequate bone height and width in the edentulous site for placement of a regular dental implant.
Restoration of implant should be possible with adequate occlusal clearance.
 
 
ExclusionCriteria 
Details  Individuals with habits such as smoking
Individuals taking calcium/ vitamin D supplementation
Individuals with other diseases which affect the bone metabolism and impair osseointegration
Individuals who are on glucocorticoid medication.
Pregnant or lactating individuals.
Individuals undergoing orthodontic therapy
Completely edentulous patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plasma activated implants will demonstrate better implant stability in Vitamin D deficient/insufficient individuals as compared to Non-activated SLA implant surfaces.  baseline, 4 weeks, 3 months , 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Plasma activated implants will demonstrate lesser marginal bone loss in Vitamin D deficient/insufficient individuals as compared to Non-activated SLA implant surfaces.   baseline, 3 months, 6 months & one year

 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   01/08/2025 
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  

All patients who meet the inclusion/ exclusion criteria will be consecutively enrolled in the trial. Each participant will be randomly assigned to receive either the plasma activated implants or Non-activated SLA implants by using a computer generated random number table. Allocation concealment will be achieved by means of a Sequentially numbered, opaque, sealed envelope (SNOSE) technique. The surgical procedures for allocated patients will be done in Department of Periodontology.

Routine Blood parameters will be checked pre-operatively (vitamin D3, BT, CT, PTT, CBC, INR) at central lab in ā€œGā€ block which is a regular protocol for patients undergoing periodontal therapy. Oral prophylaxis will be performed. CBCT will be taken to assess the bone density.

A clinical proforma will be used to document the history, medical and dental anamnesis and clinical parameters (viz) Oral Hygiene Index-Simplified (OHI-S) (Greene & Vermillion,1964), Modified gingival index for dental implants(Mombelli et al), Modified plaque index for dental implants( Mombelli et al, 1987), edentulous site parameters (MD width, WOKG, occlusal clearance, soft tissue thickness) and radiographic parameters (assessed by CBCT) bone quality and quantity, width and height. The surgical procedures will be done as follows 

Under local anaesthesia, (mixture of 2% lignocaine and 1:100,000 adrenaline) either a mid-crestal or paracrestal incision will be made with a 15c blade and BP handle No 3. A mucoperiosteal flap will be elevated and an osteotomy site will be prepared using a standard sequential drilling protocol, followed by the equi-crestal placement of an implant of suitable diameter. Before placement the implant will be irradiated with Plasma for 20 seconds using the Plasma activator (Test group). In control group SLA implants (no activation) will be placed into prepared osteotomy site. Then the stability of the implant will be assessed using an Ostell device, which employs resonance frequency analysis to provide ISQ values ranging from 1 to 100. Cover screws will be subsequently placed over the implant, and the flap will be closed with 3-0 PTFE sutures to achieve hemostasis. Impression will be made at the implant level using impression coping and custom trays, after which the permanent crowns were crafted and cemented onto the abutments. Oral hygiene instructions will be consistently emphasized throughout the study period. Patients will be recalled at 10 days and 1 month for professional oral hygiene and review; at 4 months for implant placement


 
Close