| CTRI Number |
CTRI/2024/07/069739 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Bone performance of ultraviolet light activated dental implants used for overdentures in patient with moderately controlled diabetes |
|
Scientific Title of Study
|
Comparative evaluation of implant stability quotient and marginal bone loss in conventional and Ultraviolet light photofunctionalized dental implant retained mandibular overdenture in patients with moderately controlled Diabetes Mellitus a randomized controlled clinical study |
| 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 Harshal Shailesh Jain |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9272187188 |
| Fax |
|
| Email |
hsparakh98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sethuraman |
| Designation |
Professor and Head of the department Prosthodontics crown and bridge |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9725038434 |
| Fax |
|
| Email |
rajeshsethu77academics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshal Shailesh Jain |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
K M Shah Dental college and Hospital Sumandeep vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9272187188 |
| Fax |
|
| Email |
hsparakh98@gmail.com |
|
|
Source of Monetary or Material Support
|
| material support from K M Shah Dental college and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Harshal Jain |
| Address |
No 9 Prosthodontics Crown and Bridge K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara Gujarat |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshal Shailesh Jain |
K M Shah Dental College and Hospital Sumandeep Vidyapeeth |
No 9 Department of prosthodontics crown and bridge K M Shah dental college and hospital
sumandeep vidyapeeth pipariya waghodia vadodara
Vadodara
GUJARAT |
9272187188
hsparakh98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventoional implant |
it is placed directly in patient as supplied by the manufacturer without any additional surface treatment |
| Intervention |
photofunctionalization of dental implant |
it is the modification for surface treatment for implant in which the implant will be placed in customized photofunctionalization unit for 15 minutes before implant placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a Subjects 18 years and above
b Completely edentulous upper and lower arches
c Edentulous ridge classification as per American College of Prosthodontists (ACP) type III & type lV
d Able to provide consent
e Patients with moderately controlled type 2 diabetes mellitus
f HbA1C value 6.9-8.0
g Patients whose consent for surgical placement of implants is obtained from physician treating them for diabetes
|
|
| ExclusionCriteria |
| Details |
a Patients with systemic diseases or metabolic disorders other than diabetes if any which may impact study
b Patients is currently a smoker or quit smoking less than 1 year
c Pregnant and lactating women
d Patients in whom bone grafting is indicated along with the placement of implants
e Patients in whom immediate implants are placed
f Patients who have received or are on chemotherapy or radiotherapy or drugs that interfere with implant integration
g Patients having any surgical or congenital mandibular defects
|
|
|
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 |
implant stability quotient and
marginal bone loss
|
implant stability quotient and marginal bone loss at baseline 2 months 3 months 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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)
|
31/07/2024 |
| 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
|
This is paired split mouth randomised controlled trial comparing and evaluating the implant stability and marginal bone loss is of photofunctionalized implant and conventional implant in moderately controlled diabetic patients receiving mandibular overdenture. As a part of routine blood investigation for implant placement blood sugar levels and HbA1c levels shall be obtained. Patients will be recruited after giving participation participant information sheet in the simplified language and after taking the consent for the trial. A total of 26 implants in 13 moderately controlled diabetic patients, one photofunctionalized and other conventional implants will be randomly allocated in each patient’s left or right side of the mandible as per the computer-generated random numbers. Radiographic evaluation will be done with the help of three dimensional cone beam computed tomography to evaluate the length and width of available bone and accordingly, dimensions of dental implants will be selected for placement. Implants shall be placed with conventional surgical drilling protocol as advocated by the implant manufacturer. On all the placed implants gingival former will be planned and primary closure shall be achieved by sutures. The specimens of one group of implants will be treated using a customized photofunctionalization unit for 15 minutes and then placement will be done.  The light source used will be a 125-watt to 250-watt medium-pressure mercury (Hg) lamp with dual lamp monitoring.The wavelength of the light used UV-C will be 250–260 nm As per the protocol, conventional loading shall be done after three months. Patients will be given conventional maxillary denture and lower implant supported ball attachment retained overdenture and outcomes will be measured by Implant stability instrument Resonance Frequency Analysis (RFA) at baseline 2 3 6 and 12 months and assessment of marginal bone level will be checked at baseline 2 3 6 and 12 months after implant placement with intraoral periapical radiograph. Results will be statistically evaluated.
|