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CTRI Number  CTRI/2025/07/090827 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dental implant healing in diabetes: comparing UV-treated and untreated implants 
Scientific Title of Study   A Split-Mouth Randomized Controlled Trial Comparing Soft Tissue Healing and Crestal Bone Levels Around Photo-Functionalized Versus Non-Functionalized Dental Implants in Patients with Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANKITA RAMESH GOMARE 
Designation  JUNIOR RESIDENT 1 
Affiliation  Santosh deemed to be university, Ghaziabad  
Address  Department of Prosthodontics and crown & Bridge, Santosh Dental College, Santosh Deemed to be University, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  7219033159  
Fax    
Email  ankitagomare2020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akshay Bhargava  
Designation  Dean  
Affiliation  Santosh deemed to be university, Ghaziabad  
Address  Department of Prosthodontics and crown & Bridge, Santosh Dental College, Santosh Deemed to be University, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9999960255  
Fax    
Email  akshay.bhargava@santosh.ac.in  
 
Details of Contact Person
Public Query  
Name  ANKITA RAMESH GOMARE 
Designation  JUNIOR RESIDENT 1 
Affiliation  Santosh deemed to be university, Ghaziabad  
Address  Department of Prosthodontics and crown & Bridge, Santosh Dental College, Santosh Deemed to be University, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  7219033159  
Fax    
Email  ankitagomare2020@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics and Crwon & Bridge , Santosh Dental College , Santosh Deemed to be University 1, Santosh Nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ANKITA RAMESH GOMARE  Santosh Dental College and Hospital Ghaziabad   Department of Prosthodontics and crown & Bridge, Santosh Dental College, Santosh Deemed to be University, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh , 201009
Ghaziabad
UTTAR PRADESH 		 07219033159

ankitagomare2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of santosh deemed to be university ghaziabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal (non-UV-treated) dental implants  These implants are used straight from the package without UV treatment. They are placed in the same patient for comparison.  
Intervention  Photofunctionalized dental implants   UV-treated dental implants These implants are exposed to ultraviolet (UV) light before placement. The UV light makes the implant surface more active, helping it heal better and attach to bone faster. These are called photofunctionalized implants.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Minimum of two teeth indicated for extraction on each side of the arch.
Age between 30 to 59 year
controlled diabetic status:
HbA1c : 6.5 percent to 8.0 percent
Fasting glucose : 90 to 130 mg per dl
postprandial glucose : less than 180 mg per dl
Nonsmokers
Presence of functional opposing dentition  
 
ExclusionCriteria 
Details  •Individuals with uncontrolled systemic disease like hypertension.
•Patients presenting abuse of drugs or alcohol, use of tobacco.
•Patients presenting with handicap condition that would adversely affect the capacity to maintain satisfactory oral hygiene or complete the study protocol.
•Patient with immunocompromised conditions, including HIV
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Soft Tissue Healing

Clinical evaluation of soft tissue healing around photofunctionalized and non-photofunctionalized implants.

Assessed on Day 0 (baseline), Day 3, Day 6, and Day 15 using standardized clinical parameters (e.g., redness, swelling, bleeding).

Crestal Bone Level Changes

Radiographic assessment of bone levels around the implants using Radiovisiography (RVG).

Measurements taken at baseline (implant placement), 2 months, and 4 months postoperatively.

 		 Soft Tissue Healing

Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15

Crestal Bone Level Changes

Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.

 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison between Test and Control Sites (Split-Mouth)
Comparison of healing outcomes between the UV-treated (photofunctionalized) and non-treated implants within the same patient.
Effectiveness of Photofunctionalization in Diabetic
months (bone level).
Patients
Evaluation of whether UV-treated implants lead to improved healing in controlled Type II diabetic individuals compared to untreated implants.

 		 baseline, day 3, day 15 (soft tissue)
baseline, 2 months , 4 months  
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   01/08/2025 
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="0"
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 is a split-mouth randomized controlled clinical trial designed to evaluate and compare soft tissue healing and crestal bone level changes around photo-functionalized (UV-treated) and non-functionalized dental implants in controlled Type II diabetic patients. A total of 9 patients requiring at least two immediate implants were selected, resulting in 18 implant sites. Each patient received one UV-treated implant and one non-treated implant on opposite sides of the dental arch. Soft tissue healing was clinically assessed on Days 0, 3, 6, and 15, while crestal bone levels were measured radiographically using RVG at baseline, 2 months, and 4 months post-placement. The study aims to determine the effectiveness of photofunctionalization in enhancing early soft and hard tissue healing in diabetic individuals, with the goal of improving implant outcomes in this medically compromised group. 
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