| CTRI Number |
CTRI/2025/03/082220 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the early bone to implant contact between photofunctionalized and non photofunctionalized titanium dental implant in the mandibular region – A randomized controlled trial |
|
Scientific Title of Study
|
A study to compare the early osseiontegration between photofunctionalized and non photofunctionalized titanium dental implant in the mandibular region – A randomized controlled 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 Aditi Shreya |
| Designation |
Postgraduate |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka |
| Address |
Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka
Davanagere KARNATAKA 577004 India |
| Phone |
7206943552 |
| Fax |
|
| Email |
shreyaaditi99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr khinnavar poonam |
| Designation |
professor |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka |
| Address |
Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka
Davanagere KARNATAKA 577004 India |
| Phone |
7206943552 |
| Fax |
|
| Email |
kpoonamk2000@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aditi Shreya |
| Designation |
Postgraduate |
| Affiliation |
Bapuji Dental College and Hospital, Davangere, Karnataka |
| Address |
Department of prosthodontics crown and bridge, room no -07, Bapuji Dental College and hospital, Davangere, Karnataka
Davanagere KARNATAKA 577004 India |
| Phone |
7206943552 |
| Fax |
|
| Email |
shreyaaditi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| bapuji dental college and hospital,MCC B Block, Davanagere, Karnataka 577004, India |
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Dr. ADITI SHREYA
Room number 7
Department of Prosthodontics and Crown Bridge
Bapuji Dental College and Hospital Davangere
Mobile number 7206943552 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 kinnavar poonam k |
bapuji dental college, davangere |
bapuji implant center , room number -10, bapuji dental college and hospital , davangere Davanagere KARNATAKA |
7206943552
kpoonamk2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| the institututional review board, bapuji dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Total or partially edentulous area in mandibular region who are advised for implant placement.
Patients aged 25-40 years.
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Total or partially edentulous area in mandibular region who are advised for implant placement.
2.Patient between 25-40 years |
|
| ExclusionCriteria |
| Details |
1.Systemic illnesses or metabolic conditions that may affect research
2. Pregnant women, or nursing mothers.
3.Two adjacent teeth with uncontrolled periodontal disease, caries, or radiographic or clinical symptoms of infection.
4.Conditions requiring bone graft.
5.Smokers.
6.Parafunctional habits (bruxism)
7.Current radiation, chemotherapy, or medications that interfere with the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical and radiographic outcome |
4 weeks , 8 weeks, 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implant stability quotient and reverse torque |
4 months |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
20/03/2025 |
| 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="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients fulfilling the eligibility
criteria will be chosen for the study. All the patients will be explained about
the procedures involved and those willing to be part of the study will be
enrolled. A written voluntary informed consent will be obtained from the
willing subjects. A case proforma will be made to record the history the
associated signs and symptoms.
The subjects will be equally divided in 2 groups
on the basis of age 25 to 32 years and 33 to 40 years. 6 patients from each
group will further be divided equally into 3 male and 3 female subgroups. The
subjects will be sent to control and experiment group randomly. In order to pre
decide the appropriate length and diameter of the implants, participants have
to undergo a CBCT scan prior to the surgery. The patients will also be divided
on the basis of grayscale value which will be used in future to stratify the
patient according to bone density. The surgical site will be classified into
three bone quality groups (2,3,4) on the basis of the objective evaluation of
the grayscale value measured on CBCT scans. The grayscale value above 500 will
be classified as bone quality group 2, between 300 to 500 as group 3, and
below300 as group 4. The clinician will receive implant fixture/fixtures which
is selected for each surgical case. The procedure will be conducted for each
patient. The fixture for a participant who needs multiple implant placement
will be included in the same group. Hence, the study is implant-based rather
than patient-based.
In case of the
photofunctionalized group the implant fixtures will be irradiated with a UV
machine (DIO UVirradiator) for 20 seconds, so that the desired condition as per
the manufacturer’s recommendation is achieved. After that, the implants will be
delivered to the clinician. The placement of implant will be conducted
according to the conventional procedures. Immediately
after the surgery, the implant site will be evaluated using the Intra Oral
Periapical radiograph.The stability of the implant will be assessed
using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant
stability quotient value (ISQ) will be recorded. The ISQ will be measured
immediately after placing the implant, 4 weeks ,8 weeks and 4 months post
operatively.
The intra oral periapical
radiograph will be taken immediately after placing the implant, 8 weeks and 4
months post operatively using the paralleling technique (70KV, 6mA,
120millisecond). The digital radiograph sensor will be placed parallel to the
long axis of the implant and the x-ray beam is directed perpendicular to the
receptor to visualize the pitches and platform of the fixtures on the
radiograph. A specialist who is trained in dental radiography will then
evaluate the marginal bone level of the implants in each intraoral periapical
radiograph. At first, the whole length of the fixtures will be measured for
magnification calibration of the radiographs. After that, the distance from the
platform of the fixture to the marginal bone crest is recorded both mesially
and distally. The difference between the measured value as compared to the
initial value (the value obtained immediately after the surgery) will be
calculated for each case and will be considered as bone loss. The mesial and
distal bone loss will be calculated separately and will be recorded as mesial
and distal marginal bone loss separately for each implant. At 4 months, a
reverse torque of 30N will be given to both photofunctionalized and non
photofunctionalized implant using torque wrench and implant resistance will be
checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4
months after placement of implants. The soft tissue evaluation will be done
using mouth mirror and plastic probe around using Mombelli et al (mGI). procedures. Immediately
after the surgery, the implant site will be evaluated using the Intra Oral
Periapical radiograph.
The stability of the implant will be assessed
using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant
stability quotient value (ISQ) will be recorded. The ISQ will be measured
immediately after placing the implant, 4 weeks ,8 weeks and 4 months post
operatively.
The intra oral periapical
radiograph will be taken immediately after placing the implant, 8 weeks and 4
months post operatively using the paralleling technique (70KV, 6mA,
120millisecond). The digital radiograph sensor will be placed parallel to the
long axis of the implant and the x-ray beam is directed perpendicular to the
receptor to visualize the pitches and platform of the fixtures on the
radiograph. A specialist who is trained in dental radiography will then
evaluate the marginal bone level of the implants in each intraoral periapical
radiograph. At first, the whole length of the fixtures will be measured for
magnification calibration of the radiographs. After that, the distance from the
platform of the fixture to the marginal bone crest is recorded both mesially
and distally. The difference between the measured value as compared to the
initial value (the value obtained immediately after the surgery) will be
calculated for each case and will be considered as bone loss. The mesial and
distal bone loss will be calculated separately and will be recorded as mesial
and distal marginal bone loss separately for each implant. At 4 months, a
reverse torque of 30N will be given to both photofunctionalized and non
photofunctionalized implant using torque wrench and implant resistance will be
checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4
months after placement of implants. The soft tissue evaluation will be done
using mouth mirror and plastic probe around using Mombelli et al (mGI). |