CTRI Number |
CTRI/2021/01/030194 [Registered on: 01/01/2021] Trial Registered Prospectively |
Last Modified On: |
04/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare the effect on surrounding structures by two different joints between artificial root and artificial tooth |
Scientific Title of Study
|
Evaluation of peri implant soft and hard tissues between internal hexagonal and internal conical type of implant abutment connection- A randomised controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Aditi Mishra |
Designation |
Junior resident-1 |
Affiliation |
King Georges Medical College, U.P. |
Address |
Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh King Georges Medical College,Lucknow, Uttar Pradesh Lucknow UTTAR PRADESH 226003 India |
Phone |
7599114676 |
Fax |
|
Email |
aditiara33@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Aditi Mishra |
Designation |
Junior resident-1 |
Affiliation |
King Georges Medical College, U.P. |
Address |
Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh King Georges Medical College,Lucknow, Uttar Pradesh
UTTAR PRADESH 226003 India |
Phone |
7599114676 |
Fax |
|
Email |
aditiara33@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ramashanker Siddarth |
Designation |
Professor |
Affiliation |
King Georges Medical College, U.P. |
Address |
Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh King Georges Medical College,Lucknow, Uttar Pradesh Lucknow UTTAR PRADESH 226003 India |
Phone |
9450361106 |
Fax |
|
Email |
ramashanker09@rediffmail.com |
|
Source of Monetary or Material Support
|
Department of Prosthodontics, crown and Bridge, New dental building, King George Medical College,Lucknow |
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [nil] |
|
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 |
Aditi Mishra |
King George Medical College |
Dept. of Prosthodontics, Crown & Bridge, Sixth floor, New dental building, King Georges Medical College, Lucknow, Uttar Pradesh Lucknow UTTAR PRADESH |
7599114676
aditiara33@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, King Georges Medical college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Delayed occlusal loading of implants placed in properly healed single teeth edentulous site |
After delayed occlusal loading, the peri-implant tissue is evaluated for next 12 months |
Comparator Agent |
Implant-Abutment Connection |
Two implant abutment connections- Internal Hexagonal and Internal Conical will be compared for peri-implant tissue inflammation using probing depth, bleeding on probing, IL-1 Beta levels in PICF and marginal bone loss |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patient in the age group of 18years or above who will be able to understand the procedure and be able to provide informed consent to participate in it.
2. Partially edentulous in posterior region(molar and premolar).
3. Patients with simplified oral hygiene index score less than 3
4. Patients having sufficient bone to allow optimal implant placement without the need of bone augmentation or recontouring and having sufficient distaance from vital tissues(2mm).
5. Presence of keratinized tissue more than 2mm
6. Stable posterior occlusion
7. Presence of adjacent teeth (1.5mm) |
|
ExclusionCriteria |
Details |
1. Patient with a history of systemic disease that precludes standard implant therapy.
2. Patients having parafunctional habits
3. Patient with a current daily smoking habit or chewing tobacco and with a history of drug abuse or alcoholism within past years
4. Pregnant or lactating mother
|
|
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 |
Levels of Crestal bone loss
Levels of IL-1beta
Change in probing depth
Change in bleeding on probing index |
parameters will be recorded during the time of delivery of prosthesis
3 months after occlusal loading
6 months after occlusal loading
12 months after occlusal loading |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/01/2021 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Dental implant treatment is widely used to reconstruct functional and aesthetic problems in partially and fully edentulous patients. However, implant-prosthetic treatment is not free of possible complications and limitations.Stability of peri-implant tissues appears to be one critical component for long term implant success and is influenced by many factors including surgical trauma, biological width establishment, lack of passive fit of superstructures, implant-abutment connection, etc. The type of implant-abutment connection(IAC) has been considered to be one of the major factors affecting the peri-implant hard and soft tissues. IAC is the point of contact between the surgical and prosthetic phase and is required to provide adequate joint strength, rotational stability, prosthetic indexing and resistance to microbial penetration. IAC are of two types- External and Internal connection. Internal connection are further diversified into numerous design in an attempt to achieve better microbial seal and joint stability which include internal hex and internal conical. Few studies have been conducted on comparing these two internal connections and the obtained results were variable. The purpose of the study is to comparatively evaluate the effect of two implant abutment connection- internal hexagonal and internal conical on peri-implant soft and hard tissue after occlusal loading. This evaluation will be done based on following parameters- 1. Hard tissue parameter- Crestal bone loss 2. Soft tissue parameters- Probing depth and bleeding on probing 3. IL-1 beta levels in peri-implant sulcus fluid. These parameters will be recorded during delivery of prosthesis (before occlusal loading-baseline) and 3, 6 and 12 months after occlusal loading. The recorded data will be tabulated and analysed and results will be drawn. |