| CTRI Number |
CTRI/2022/03/041078 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
12/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which type of implant placement provides better clinical outcome in patients? |
|
Scientific Title of Study
|
Clinical performance, patient and operator reported outcome measures of axially placed and tilted implants used for fixed rehabilitation of the edentulous maxilla: A pilot study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Kheur |
| Designation |
Professor, Head of Implantology. |
| Affiliation |
M.A.Rangoonwala College of Dental Sciences and Research Center, Pune |
| Address |
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
989350037 |
| Fax |
|
| Email |
mkheur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tabrez lakha |
| Designation |
Senior Lecturer, Department of Prosthodontics |
| Affiliation |
M.A.Rangoonwala College of Dental Sciences and Research Center, Pune |
| Address |
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Pune
MAHARASHTRA
400102
India |
| Phone |
09766675324 |
| Fax |
|
| Email |
tabrezlakha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farha Rizwan |
| Designation |
Study Manager |
| Affiliation |
M.A.Rangoonwala College of Dental Sciences and Research Center, Pune |
| Address |
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
989350037 |
| Fax |
|
| Email |
dr.farha.mardc@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Team For Implantology |
|
|
Primary Sponsor
|
| Name |
International Team For Implantology |
| Address |
Peter Merian-Weg 10,
4052 Basel
Switzerland |
| Type of Sponsor |
Research institution |
|
|
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 |
| Mohit kheur |
M.A. Rangoonwala College of Dental Sciences and Research Centre |
Department of Prosthodontics & Implantology, Room no. 301, M.A.Rangoonwala College of Dental Sciences and research Centre, Hidayatullah road, Azam Campus, Camp, Pune 411001
Pune
MAHARASHTRA |
989350037
mkheur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of M.A.Rangoonwala Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Absence of teeth in the upper jaw (maxilla) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD-CAM fabricated provisional prosthesis |
Duration: 3 months.
CAD-CAM fabricated provisional prostheses facilitates prosthesis delivery in immediate functional loading protocols. The prostheses are manufactured in the laboratory by milling high-density polymers based on a highly cross-linked polymethylmethacrylate (PMMA). The prostheses are known to have higher biocompatibility, superior esthetics and soft tissue response as compared to denture conversion prostheses.
|
| Comparator Agent |
Denture Conversion Prosthesis |
Duration: 3 months.
The denture conversion prosthesis is routinely used for immediate loading of complete-arch fixed implant-supported prosthesis due to its simplicity, adaptability to changes in planned implant positions, and reduced treatment cost. Nevertheless, this is a multistep, technique-sensitive process. Therefore, in this study a comparison between CAD-CAM fabricated prostheses and a denture conversion prostheses will be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients should be of minimum 18 years to be included in the study.
- Patient with edentulous maxilla
- Presence of natural teeth or dentures in the mandibular arch
- Presence of adequate primary stability during implant placement.
- Adequate bone volume to place at least 4 implants with a standard diameter & at least 6 mm in length.
- Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar).
- Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region to place an implant of a regular diameter with a minimum length of 8 mm.
- Presence of healed maxillary edentulous ridge (at least 3 months post extraction).
|
|
| ExclusionCriteria |
| Details |
Self reported history of bruxism
- Uncontrolled diabetes (HbA1c>7.5 mg/dl)
- History of irradiation in the head and neck region
- Inability to comply with annual implant maintenance follow up
- Ridge profile not allowing the placement of a fixed prostheses.
- Presence of systemic disease that contraindicates implant placement.
- Pregnant or lactating women
|
|
|
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 |
| The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Survival rates:
To evaluate implant survival rates of tilted and axially placed implants at 1 year, 3 years and 5 years
.
VAS Scores, OHIP-14 scores and Operator based preferences. |
1 year, 3 years and 5 years |
Prosthetic Level:
Incidence of chipping of the final prostheses, fracture of abutment/ crown or frame work, fracture of veneering ceramic, occlusal roughness, loss of retention (loosening of crown or abutment screw) and the contour of restoration will be evaluated at 4 weeks after insertion of final prosthesis and at 1 year, 3 years and 5 years after function for final prosthesis using the Modified USPS scores.
|
4 weeks, 1 years, 3 years and 5 years |
Implant Level:
Fracture of screw and implant will be evaluated at 4 weeks after insertion of final prosthesis (BL1) and at 1 year, 3 years and 5 years.
|
4 weeks, 1 years, 3 years and 5 years |
PROMS:
- VAS scores based questionnaires about maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at insertion of interim prosthesis ( Visit 3; prior to implant insertion,) at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses (BL1) and at 1, 3 and 5 years after function.
- OHIP-14 will be evaluated at insertion of interim prosthesis (Visit 3; prior to implant insertion, at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses and at 1, 3 and 5 years after function.
|
1 year, 3 years and 5 years |
Operator based preferences:
VAS scores based questionnaires for operator based preferences with respect to the ease of surgery and insertion of CAD-CAM fabricated provisional prostheses and denture conversion prostheses will be assessed after the insertion of provisional prostheses.
|
3 months |
Clinical outcomes:
The following clinical outcomes will be evaluated at baseline after a functional period 3 months for provisional prostheses; and after insertion of final prosthesis (BL1) and after a functional period of 1, 3 and 5 years by using a dental probe
- Probing depth (PD)
- Bleeding on probing (BOP)
- Plaque control record (PCR)
|
3 months, 1 year, 3 years and 5 years |
Radiographic Outcomes
Crestal bone loss |
3 months, 1 year, 3 years and 5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/03/2022 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Implant supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws. The concept of tilted implants is well documented in the dental literature and high implant survival and success rates for rehabilitation of edentulous arches have been reported.Even though the concept of tilted implants is documented in the literature, the majority of the studies performed evaluated the success and survival rates of this technique without a proper control group.Therefore, in this study, besides the comparison between the two different reconstruction workflows , the patients will be randomized to receive axially or tilted implants. Overall, the expected outcome of this study might help clinicians in their decision making-process when rehabilitating cases of atrophic maxilla. |