| CTRI Number |
CTRI/2022/02/039915 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
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Public Title of Study
|
A comparative evaluation of prosthetic and biological outcome of two different implant restorative materials |
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Scientific Title of Study
|
A comparative evaluation of prosthetic and biological outcome as influenced by two different implant restorative materials (porcelain fused to metal and monolithic zirconia) - A prospective, cross arch study |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Taniya Malhotra |
| Designation |
PG student |
| Affiliation |
Department of Prosthodontics, Faculty of Dental sciences,SGT University |
| Address |
Sector C Pocket 8 House No 8701
Vasant Kunj
New Delhi-110070
South West
DELHI
110070
India |
| Phone |
09560886370 |
| Fax |
|
| Email |
taniyamalhotra08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
Department of Prosthodontics, Faculty of Dental sciences, SGT University |
| Address |
SGT University, Faculty of Dental Sciences, Gurugaon
Haryan
Gurgaon
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
drbhupinderyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
Department of Prosthodontics, Faculty of Dental sciences, SGT University |
| Address |
SGT University, Vill. Budhera, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
drbhupinderyadav@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Taniya Malhotra |
| Address |
Sector C Pocket 8 House no 8701
Vasant kunj
New Delhi-110070 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Taniya Malhotra |
SGT University |
Department of Prosthodontics, Room no 3,Faculty of Dental Sciences
Gurgaon
HARYANA |
9560886370
taniyamalhotra08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of faculty of dental sciences SGT University |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BILATERAL MISSING POSTERIOR TEETH |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant supported fixed dental prosthesis |
Intervention of two different type of implant supported fixed dental prosthesis- Porcelain fused to metal and monolithic zirconia. |
| Comparator Agent |
Implant supported fixed dental prosthesis and natural teeth |
Comparison of two different implant supported restorative materials- Porcelain fused to metal and monolithic zirconia with natural teeth |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Two implants placed in the same arch in posterior quadrant requiring prosthodontic rehabilitation.
2.Interocclusal restorative space of 8-10 mm
3.Healthy Periodontium with no visible signs of bruxism
4.Stable and healthy implants with no crestal bone loss
|
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| ExclusionCriteria |
| Details |
1. According to ASA Classification Class 4 patients:
Organic heart disease with marked signs of cardiac insufficiency
Recent myocardial infarction of less than 6 months duration.
Unstable angina.
Patients with advanced degrees of pulmonary, renal or endocrine insufficiency
2. According to ASA Classification Class 3 patients
Diabetes with complications to vascular or other organs, i.e., retinopathy, neuropathy, etc.
3. Occlusal anomalies
Deep Bite
Cross Bite
4. Long term edentulism leading to mesial drifting of adjacent teeth or supraaeruption of opposing teeth
5. Para-functional Habits (Bruxism)
6. Smokers
7. Active periodontal disease
8. Allergy to materials used in the study
9. Current drug abuse
10. Pregnant or intend to become pregnant.
11. Severe salivary gland dysfunction.
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
primary outcome will determine which restoration will be more suitable for implant supported prosthesis.
The suitabilty of the restorations will depend on the prosthetic and biologic outcome which will include ceramic fracture, screw loosening, marginal fit, color match, occlusal wear, bleeding on probing, plaque deposition etc |
primary outcome will determined at baseline, 6 months and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To Determine the biological outcome through evaluation of inflammatory markers of two different implant restorative materials. The inflammatory marker to be evaluated is MMP-8. |
Biological outcome will be assessed at baseline, 6 months and 12 months |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/02/2022 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
TITLE: A COMPARATIVE EVALUATION OF
PROSTHETIC AND BIOLOGICAL OUTCOME AS INFLUENCED BY TWO DIFFERENT IMPLANT
RESTORATIVE MATERIALS (PORCELAIN FUSED TO METAL AND MONOLITH ZIRCONIA)“ - A PROSPECTIVE, CROSS ARCH STUDY
BACKGROUND: For proof of the change of material choice from metal ceramic to zirconia,
clinical studies are needed which are lacking in the literature and there is a
lacunae regarding comparison of zirconia and
metal ceramic reconstructions in relation to implant supported restorations.
AIM: To evaluate and compare the prosthetic parameters, clinical indices, crestal bone levels and inflammatory biomarkers in peri implant crevicular fluid as influenced by two
different implant restorative materials (porcelain fused to metal and
monolithic zirconia) at baseline, 6 months and 1 year
METHODOLOGY: 20 patients will be selected from the outpatient department of
Department of Prosthodontics, Faculty of Dental Science SGT University. Second stage surgery will be performed and healing abutments will be
placed for one week. After one-week healing caps will be removed and
final impression will be made using closed or open tray impression technique
using polyether impression material. Alginate will be used
for the impression of the opposing jaw, and silicone will be applied for the
bite registration. All crowns will be fabricated by one experienced master
dental technician. Mono-ZrO2 crowns will be fabricated using a laboratory-based
CAD and an industrial CAM process. For the PFM group, conventional model will
be used for the fabrication of the PFM crown. The conventional manufacturing
will include the lost-wax technique for the casting of the base metal core
followed by manual layering of the veneering ceramic followed by ceramic firing
according to the manufacturers’ instructions. the crowns will be adjusted in
the mouth and polished or glazed after which they will be cleaned with ethanol
solution and cemented with resin cement. the access hole will be blocked using
flowable composite resin. Immediately following cementation of the
restorations clinical status using modified USPHS criteria and periodontal
status around the implant restored with porcelain fused to metal, implant
restored with zirconia and the natural teeth in the same arch will be recorded
by applying the following clinical indices i.e. bleeding on probing, plaque
index, probing depth and width of keratinized gingiva. For the indices and
measurement of probing depth a Williams probe will be used. The examination
will involve the use of a thin periodontal probe with Williams marking (at 1,
2, 3, 5, 7, 8, 9, and 10 mm), the entire sulcus of the restored implant and the
control tooth will be probed, and a reading will be taken. The total technical complication rate on the
prosthetic level (primary outcome) will include fracture of the veneering
ceramic, fracture of the crown, fracture of the abutment, fracture of the
abutment screw, loosening of the abutment screw, loss of the occlusal filling, and
decementation. Crestal bone levels will be measured using RVG Inflammatory markers in the PICF will be measured using ELISA. Statistical Analysis: Resulting data will be analyzed statistically.
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