CTRI Number |
CTRI/2021/12/038506 [Registered on: 08/12/2021] Trial Registered Prospectively |
Last Modified On: |
15/03/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Screw retained maxillary anterior crowns on implants |
Scientific Title of Study
|
“ EVALUATION OF BIOLOGICAL, MECHANICAL AND PATIENT REPORTED PARAMETERS ASSOCIATED WITH ANGULATED SCREW CHANNEL ABUTMENTS AND MULTI UNIT ABUTMENTS FOR FABRICATION OF SCREW RETAINED IMPLANT CROWNS IN ANTERIOR ESTHETIC ZONE – AN IN VIVO STUDY.†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Niyati Varshney |
Designation |
Post Graduate student |
Affiliation |
Subharti Dental College and Hospital Swami Vivekanand Subharti University |
Address |
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Meerut UTTAR PRADESH 250005 India |
Phone |
7895306191 |
Fax |
|
Email |
niyati_manu1994@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Chandan Kumar Kusum |
Designation |
Associate Professor |
Affiliation |
Subharti Dental College and Hospital Swami Vivekanand Subharti University |
Address |
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Meerut UTTAR PRADESH 250005 India |
Phone |
9627600077 |
Fax |
|
Email |
ckkusum@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Niyati Varshney |
Designation |
Post Graduate student |
Affiliation |
Subharti Dental College and Hospital Swami Vivekanand Subharti University |
Address |
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital
Swami Vivekanand Subharti University
Meerut Uttar Pradesh Meerut UTTAR PRADESH 250005 India |
Phone |
7895306191 |
Fax |
|
Email |
niyati_manu1994@yahoo.co.in |
|
Source of Monetary or Material Support
|
Vinesh Kumar Varshney
House no 786
sector 11
Vasundhara
Ghaziabad
Uttar Pradesh
201012 |
|
Primary Sponsor
|
Name |
Dynamic Abutment Solutions |
Address |
Geoda Medical SL
Cl Virginia Woolf 17
25005 Lleida
Spain |
Type of Sponsor |
Other [company] |
|
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 |
Niyati Varshney |
Subharti Dental College |
Room no 6
Department of Prosthodontics and Crown & Bridge
Swami Vivekanand Subharti University Subharti Puram
NH-58
Delhi Haridwar Meerut Bypass Road
Meerut
Uttar Pradesh
250005 Meerut UTTAR PRADESH |
7895306191
niyati_manu1994@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
university ethics committee (medical) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
maxillary anterior edentulism |
Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Angulated Screw Channel abutment |
Angulated Screw Channel technology changes the screw accessibility from palatal direction, rather than the prosthetic screw direction. |
Comparator Agent |
Multi unit abutments |
Multi unit abutments brings the screw access hole palatally by changing the prosthetic screw direction. Also, these definitive MUAs enable better hemidesmosomal adherence between the soft tissue and titanium and therefore might reduce bone resorption around the implants. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Patient willing for the procedure (the study is explained, including the procedure and follow up for evaluation)
2) Patient that has good oral hygiene and periodontal health (patients that can follow up for evaluation)
3) Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration
4) Implant site free from infection
|
|
ExclusionCriteria |
Details |
1. Medical and general contraindications for the surgical procedures
2. Presence of active and uncontrolled periodontal disease
3. History of local radiotherapy to the head and neck region.
4. Systemic diseases (Uncontrolled diabetes, recent MI, valvular prosthesis surgery, bleeding disorders, acute renal failure, immunosuppression).
5. Patients in intravenous bisphosphonate.
6. Psychiatric illness
7. Chronic heavy smokers
8. History of head and neck irradiation in the last 6 months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Angulated screw channel abutment and multi unit abutment can alter angulation of screw hole and used in anterior screw retained prosthesis. |
at baseline prosthesis delivery
6 months
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
biological, mechanical and patient reported parameters |
at baseline
6 months
1 year |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/12/2021 |
Date of Study Completion (India) |
30/01/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
in peer review |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study was conducted in the Department of Prosthodontics
and Crown & Bridge, Subharti Dental College and Hospital, Meerut is
to evaluate biological, mechanical and patient reported parameters
associated with Angulated Screw Channel abutments and Multi unit
abutments for fabrication of screw retained implant crowns in anterior
esthetic zone. For the study 20 patients were selected who needed
implants in maxillary anterior region. The implants were placed either
crestal or subcrestal position to accommodate the angulated
abutments (Angulated Screw Channel and Multi unit abutments) in a
way that it lie within the prosthetic envelop. Depending on the group
assigned, a screw retained crown was made either on ASC abutment
or MU abutment. All the parameters were evaluated at the time of
crown placement and 12 months after crown placement. The data then
was statistically evaluated and compared.
In the present study, implant survival was found 100% in both
groups. MBL decreased significantly from baseline to 1-year follow-up
in both groups. MBL in the MU group was slightly lower than in the
ASC group but this difference was not statistically significant. Also, no
statistically significant difference was found in the modified plaque
index, modified sulcus index, and gingival index at baseline and 1-year
follow-up values in both groups. The RTL value was significantly lower (p<0.003) in the ASC
group than MU group at baseline, however, no statistically significant
difference in RTL and screw loosening was found at 1-year follow-up
between both the groups. There was no statistically significant
difference in patient-reported parameters.
Limitations of this study were the small sample size and short-term follow-up period. The high cost and limited documented clinical
success rate of these abutments as single-unit implant restoration have
restricted their application in day-to-day practice. Thus, prospective
studies with long-term follow-ups and larger sample sizes are required
to understand the possible biological, mechanical and patient-reported
parameters, and draw concrete decisions about the superiority of either
of the abutments.
Within the limitations of this study, it can be stated that the ASC
and MU abutments with anti-rotation feature can be used as an
effective alternative for screw retained restorations in cases of non-axially loaded implant with excellent clinical performance after 1 year of
function. |