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
|
|
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
āGā 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 |