| CTRI Number |
CTRI/2025/07/090131 [Registered on: 03/07/2025] 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 Trial |
|
Public Title of Study
|
A study to compare different types of implant connections based on its aesthetics, survival rate and gingival health |
|
Scientific Title of Study
|
Comparison of the effect of different types of custom abutments on aesthetic and survival outcomes, and peri-implant tissue health - A randomised control 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 |
Krishnaprasad A |
| Designation |
Junior resident |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Prosthodontics, Room no.51, 4th Floor, Government Dental College, Government Medical College,
Kozhikode
KERALA
673008
India |
| Phone |
9496651997 |
| Fax |
|
| Email |
krishnaprasada.97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar A V |
| Designation |
Head of the department |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Prosthodontics, Room no.51, 4th Floor, Government Dental College, Government Medical College,
Kozhikode
KERALA
673008
India |
| Phone |
9447169055 |
| Fax |
|
| Email |
pramodav@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnaprasad A |
| Designation |
Junior resident |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Department of Prosthodontics, Room no.51, 4th Floor, Government Dental College, Government Medical College,
Kozhikode
KERALA
673008
India |
| Phone |
9496651997 |
| Fax |
|
| Email |
krishnaprasada.97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College, Government Medical College, Kozhikode, 673008 |
|
|
Primary Sponsor
|
| Name |
Krishnaprasad A |
| Address |
Government Dental College, Government Medical College, Kozhikode, 673008 |
| 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 |
| Krishnaprasad A |
Department of Prosthodontics, Government Dental College, Kozhikode |
Department of Prosthodontics, Room no.51, 4th floor, Government Dental College, Kozhikode, 673008
Thrissur
KERALA |
9496651997
krishnaprasada.97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE, KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients with missing teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group MPA: Implants with milled PEEK custom abutment.
Group ZHA: Implants with Zr hybrid custom abutment.
Group PHA: Implants with PEEK hybrid custom abutment.
Group DMLS: Implants with DMLS Co-Cr custom abutment.
|
In the above mentioned group the following parameters are assessed:
1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months.
2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months.
3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months.
4.Survival rate of prosthesis: After 3 months and 6 months.
|
| Comparator Agent |
Group PFT: Implants with prefabricated titanium implant abutments. |
In the above mentioned group the following parameters are assessed:
1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months.
2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months.
3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months.
4.Survival rate of prosthesis: After 3 months and 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of age 18 - 60 years regardless of the gender.
2.Patients with single or multiple missing teeth to be replaced by implant prosthesis.
3.Patients with good oral hygiene and without any uncontrolled periodontal disease.
4.Sufficient mesio-distal and apico-coronal space for implant prosthesis placement.
5.Patients having stable occlusion.
6.Systemically healthy participants without any history of periodontal disease and smoking. |
|
| ExclusionCriteria |
| Details |
1.Patients developing systemic diseases during the study that would interfere with dental implant therapy.
2.Patients who are pregnant or becoming pregnant during the course of the study.
3.Patients failing to obtain osseointegration after implant placement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI)
2.Marginal bone level
3.Pink esthetic score (PES)
4.Survival rate of prosthesis
|
1.Gingival health: which include peri implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1 week after final prosthesis insertion, 3 months and 6 months.
2.Marginal bone level: Immediately after final prosthesis insertion, 3 months and 6 months.
3.Pink esthetic score (PES): during the final prosthesis delivery and at 3 months and 6 months.
4.Survival rate of prosthesis: After 3 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2025 |
| 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="2"
Months="0"
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
|
Comparison of the effect of different
types of custom abutments on aesthetic and survival outcomes, and peri-implant
tissue health - a randomised control trial. This study investigates the gingival
health, marginal bone level, pink esthetic score and survival rate of
prosthesis in 5 different groups with different types of implant abutments. The
groups are Group PFT: Implants with prefabricated titanium implant abutments. Group
MPA: Implants with milled PEEK custom abutment. Group ZHA: Implants with Zr
hybrid custom abutment. Group PHA:
Implants with PEEK hybrid custom abutment. Group DMLS: Implants with DMLS Co-Cr
custom abutment. sample size of the study is 50 and the study period is 2 years. The null hypothesis states that there is no significant difference in
terms of aesthetic and survival outcomes, and peri-implant tissue health of Groups:
MPA, ZHA, PHA and DMLS when compared to prefabricated titanium implant
abutments (PHA).
The outcomes are assessed as follows
Gingival health: which include peri
implant pocket depth (PPD), bleeding on probing (BOP) and plaque index (PI) at 1
week after final prosthesis insertion, 3 months and 6 months. Marginal bone
levels immediately after final prosthesis insertion, 3 months and 6 months. Pink
esthetic score (PES) during the final prosthesis delivery and at 3 months and 6
months. Survival rate of prosthesis after 3 months and 6 months. |