| CTRI Number |
CTRI/2025/11/096781 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Implant Abutment Materials On Bone And Gingival Health: A Split Mouth Study on Titanium and Zirconia Abutments. |
|
Scientific Title of Study
|
Comparative Evaluation Of The Titanium And Zirconia Implant Abutment On Crestal Bone Loss And Probing Depth In Posterior Region: A Split Mouth 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 Prasad Najpande |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital , Hingna, Nagpur |
| Address |
104 First Floor Department of Prosthodontics Crown And Bridge
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna Nagpur Maharashtra India
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9404064753 |
| Fax |
|
| Email |
najpandeprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishankumar Lahoti |
| Designation |
Reader And PG Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital , Hingna, Nagpur |
| Address |
104 First Floor Department of Prosthodontics Crown And Bridge
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna Nagpur Maharashtra India
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09763711501 |
| Fax |
|
| Email |
kk.lahoti@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishankumar Lahoti |
| Designation |
Reader And PG Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital , Hingna, Nagpur |
| Address |
104 First Floor Department of Prosthodontics Crown And Bridge
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna Nagpur Maharashtra India
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09763711501 |
| Fax |
|
| Email |
kk.lahoti@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Prasad Najpande |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital
Hingna Nagpur Maharashtra |
| 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 Prasad Najpande |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
104, Department Of
Prosthodontics, Crown
And Bridge, Swargiya
Dadasaheb Kalmegh
Smruti Dental College
and Hospital, Hingna,
Nagpur, Maharashtra
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9404064753
najpandeprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant abutment |
Titanium abutment |
| Comparator Agent |
Implant abutment |
Zirconia abutment |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-60 years
Bilateral Osseo integrated implant sites
No occlusal disharmony
Sufficient quantity of bone
Good oral hygiene |
|
| ExclusionCriteria |
| Details |
Immunocompromised state
Chronic bone disease
Psychiatric disorder
Uncontrolled diabetes
Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the effect of titanium implant abutments on crestal bone loss and
probing depth in posterior region.
2)To evaluate the effect of zirconia implant abutments on crestal bone loss and
probing depth in posterior region.
3)To compare the effect of titanium and zirconia implant abutments on crestal
bone loss and probing depth in posterior region. |
1)To evaluate the effect of titanium implant abutments on crestal bone loss and
probing depth in posterior region.
2)To evaluate the effect of zirconia implant abutments on crestal bone loss and
probing depth in posterior region.
3)To compare the effect of titanium and zirconia implant abutments on crestal
bone loss and probing depth in posterior region. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 1 |
|
Date of First Enrollment (India)
|
21/11/2025 |
| 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="3"
Days="2" |
|
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
|
INTRODUCTION- The field of dental implants has advanced significantly, bringing innovation
with increasing range of treatments and offering a durable solution for tooth loss.
One such aspect is specifically related to the prosthetic abutments. The
success of dental implants heavily relies on the materials used for abutments, which
connect the implant to the prosthetic tooth. The abutments attach to the
implant platform and serves as the connection point between the future
substructure of the prosthesis and the fixture. Two commonly used materials
for implant abutment are zirconia and titanium. Titanium is on a leading position
as an abutment material due to the better biocompatibility and mechanical
characteristics. Titanium alloys are used to create custom titanium abutments. However, the optical result may be harmed if the metallic colour of the
abutment continues to shine through the mucosa, which could make the
appearance of artificial gingiva.
The development of the tooth-coloured ceramic and personalized implant
abutment is result of consumer demand for extremely aesthetic restorations. Zirconia is superior to titanium with respect to the crestal bone loss and probing
depth in patients’ oral cavity. From an aesthetic point of view, the customized
zirconia abutments are advised to the patients with thin gingival biotype, but for
long term clinical function, titanium abutments are still considered better than
zirconia. OBJECTIVES-To evaluate the effect of titanium implant abutments on crestal bone loss and
probing depth in posterior region over 1 year follow-up.
To evaluate the effect of zirconia implant abutments on crestal bone loss and
probing depth in posterior region over 1 year follow-up.
To compare the effect of titanium and zirconia implant abutments on crestal
bone loss and probing depth in posterior region over 1 year follow-up. METHOD OF MEASUREMENT- 21 patients will be chosen for delayed loading dental implants in whom one
side will be loaded with titanium abutment, while other side will be loaded
with zirconia abutment. After second stage surgery, healing abutment will be
attached to the implant. Scanned bodies will be attached at the implant site
and an intraoral scan will be performed. After scanning, a model will be
obtained from 3D imaging. On the obtained model the implant abutments will
be made. The patient will be recalled and the abutments will be attached to
implant with screw intraorally. After the attachment of abutments, abutment
level impression will be taken with polyvinyl siloxane impression material and
the impression will be poured with die stone. The cast will be retrieved and
layered zirconia crown will be fabricated according to the abutment. The
patient will be recalled and the crown will be cemented over the abutment.
The baseline data of crestal bone loss and probing depth will be noted. The
data for crestal bone loss will be obtained from Gallilio cone beam computed
tomography software and the data for probing depth will be obtained by
William’s probe. The patient will be recalled after one year and the data of
crestal bone loss and probing depth will be obtained again. By comparing the
obtained values of baseline and one year follow-up, the results will be
obtained. |