Clinical Efficacy of Plasma Activated Dental Implants in Individuals with Vitamin D Deficiency/Insufficiency - A Randomized Controlled Clinical Trial

Phase 3

Not yet recruiting

• Conditions: Vitamin D Deficiency/Insufficiency

• Registration Number: CTRI/2025/05/087428
• Lead Sponsor: Dr Arvinda Siva J

Brief Summary

All patients whomeet the inclusion/ exclusion criteria will be consecutively enrolled in thetrial. Each participant will be randomly assigned to receive either the plasmaactivated implants or Non-activated SLA implants by using a computer generated randomnumber table. Allocation concealment will be achieved by means of a Sequentiallynumbered, opaque, sealed envelope (SNOSE) technique. The surgical proceduresfor allocated patients will be done in Department of Periodontology.

Routine Blood parameters will bechecked pre-operatively (vitamin D3, BT, CT, PTT, CBC, INR) at central lab in“G” block which is a regular protocol for patients undergoing periodontaltherapy. Oral prophylaxis will beperformed. CBCT will be taken to assess the bone density.

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

Under localanaesthesia, (mixture of 2% lignocaine and 1:100,000 adrenaline) either amid-crestal or paracrestal incision will be made with a 15c blade and BP handleNo 3. A mucoperiosteal flap will be elevated and an osteotomy site will beprepared using a standard sequential drilling protocol, followed by theequi-crestal placement of an implant of suitable diameter. Before placement theimplant will be irradiated with Plasma for 20 seconds using the Plasmaactivator (Test group). In control group SLA implants (no activation) will beplaced into prepared osteotomy site. Then the stability of the implant will beassessed using an Ostell device, which employs resonance frequency analysis toprovide ISQ values ranging from 1 to 100. Cover screws will be subsequentlyplaced over the implant, and the flap will be closed with 3-0 PTFE sutures toachieve hemostasis. Impressionwill 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 studyperiod. Patients will be recalled at 10 days and 1 monthfor professional oral hygiene and review; at 4 months for implant placement

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-08
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sri Ramachandra Dental College and Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Dental College and Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Arvinda Siva J

Principal investigator

7550191145

d0624003@sriher.edu.in