| CTRI Number |
CTRI/2024/03/064442 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand how the different coverings on the surface of connector piece(between implant and artificial tooth) affects the soft tissue around implant and its visual appearance. |
|
Scientific Title of Study
|
Assessment of Anodised Titanium and Zirconium Dioxide Abutments on Peri Implant Soft Tissue Thickness and its optical outcome- A Randomised Clinical 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 |
Sakshi Agarwal |
| Designation |
Academic Junior Resident |
| Affiliation |
IMS BHU , Varanasi |
| Address |
3rd Floor, Depart Of Periodontology
Faculty Of Dental Sciences
BHU Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7880827267 |
| Fax |
|
| Email |
agarwal.sakshi1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Agarwal |
| Designation |
Academic Junior Resident |
| Affiliation |
IMS BHU , Varanasi |
| Address |
3rd Floor, Depart Of Periodontology
Faculty Of Dental Sciences
BHU Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7880827267 |
| Fax |
|
| Email |
agarwal.sakshi1508@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Agarwal |
| Designation |
Academic Junior Resident |
| Affiliation |
IMS BHU , Varanasi |
| Address |
3rd Floor, Depart Of Periodontology
Faculty Of Dental Sciences
BHU Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7880827267 |
| Fax |
|
| Email |
agarwal.sakshi1508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University,Varanasi - 221005 |
|
|
Primary Sponsor
|
| Name |
Sakshi Agarwal |
| Address |
3rd Floor,Department Of Periodontology,Faculty Of Dental Sciences , IMS BHU , Varanasi- 221005 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Farhan Durrani |
IMS BHU |
Room no.05 , 3rd Floor , Department Of Periodontology, Faculty of Dental Sciences, IMS BHU , Varanasi- 221005
Varanasi
UTTAR PRADESH |
9335873366
durranif88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IMS,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Assessing the influence of Zirconium Dioxide Abutment on Peri Implant Soft Tissue Thickness and Optical Outcome of Implant supported prosthesis . |
Surgical intervention will be performed under LA.Each subject will receive an internal hex connection implant in edentulous anterior maxillary area .After 2-3 months of healing period,healing abutment will be connected.Customised abutments will be made of Zirconium Dioxide and definitive prosthesis will be fabricated. The influence of Anodised Titanium Abutment on Optical outcome and Peri-Implant soft tissue thickness of Zirconia Prosthesis will be evaluated . |
| Intervention |
Assessing the influence of Anodised Titanium Abutment on Peri Implant Soft Tissue Thickness and Optical Outcome of Implant supported prosthesis . |
Surgical intervention will be performed under LA.Each subject will receive an internal hex connection implant in edentulous anterior maxillary area .After 2-3 months of healing period,healing abutment will be connected.Customised abutments will be made of Anodised Titanium and definitive prosthesis will be fabricated. The influence of Anodised Titanium Abutment on Optical outcome and Peri-Implant soft tissue thickness of Zirconia Prosthesis will be evaluated . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Implant placement in anterior maxillary region.
2. Edentulous ridge having natural teeth both mesially and distally.
3. Presence of more than 2mm band of Keratinized tissue.
4. Systematically healthy patients.
4. Subjects with good plaque control ,showing good compliance, willing to participate in study. |
|
| ExclusionCriteria |
| Details |
a) Current untreated gingivitis or periodontitis
b) Patient under drugs than can influence healing
c) Pregnant or lactating women
d) Patients with inadequate oral hygiene or motivation for adequate home care.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Primary Implant Stability
2. Secondary Implant Stability |
1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement
2. Time Point for Secondary Implant Stability is- 3 months after Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Soft Tissue Thickness at Peri Implant Site
2. Optical outcome of Anodised Titanium Abutment & Zirconium Dioxide Abutment |
1. 2 weeks after placement of abutments.
2. 2 weeks after placement of Prosthesis. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="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
|
The quality ,structure ,thickness and color of soft tissues around implant-supported FDPs (Fixed Dental Prosthesis) may affect esthetic results . Custom-made abutments are usually fabricated from Grade-5 Titanium alloys ( 90% titanium, 6% aluminium and 4% vanadium) .However ,their metallic color may still shine through the mucosa ,impairing the optical outcome.Titanium abutments are very stable from mechanical point of view ,but they have limitations in esthetically delicate areas. Anodisation of alloys is an electrolytic passivation process used to increase the thickness of natural oxide layer on the surface of metals .This method can generate a pink tone that may mask the metallic color of titanium abutments in esthetic region.
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