| CTRI Number |
CTRI/2025/02/080376 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of clinical effect of composite layered polyetheretherketone (PEEK) crown and porcelain fused to metal (PFM) crown: a ranndomized controlled clinical study |
|
Scientific Title of Study
|
Evaluation and comparison of clinical performance of composite layered polyetheretherketone (peek) full coverage crown and porcelain fused to metal (pfm) full coverage crown: a randomized controlled clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhwani Patel |
| Designation |
M.D.S student |
| Affiliation |
Manubhai Patel dental college and hospital |
| Address |
Department of Prosthodontics, crown and bridge including implants, Manubhai Patel dental college and hospital, vishwajyoti ashram, munj mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
8160490999 |
| Fax |
|
| Email |
dhwani081@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeksha Gupta |
| Designation |
Professor M.D.S. Prosthodontist |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics, crown and bridge including implants, Manubhai Patel dental college and hospital, vishwajyoti ashram, munj mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
8141007846 |
| Fax |
|
| Email |
dr.deeksha.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Gupta |
| Designation |
Professor M.D.S. Prosthodontist |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics, crown and bridge including implants, Manubhai Patel dental college and hospital, vishwajyoti ashram, munj mahuda,Vadodara, Gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
8141007846 |
| Fax |
|
| Email |
dr.deeksha.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Crown and Bridge including Implantology, Manubhai patel dental college and hospital,near vishwajyoti ashram, vadodara, gujarat, India-390011 |
|
|
Primary Sponsor
|
| Name |
Dr Dhwani Patel |
| Address |
3 , Raghuvir stationary opp deaf and dumb school ambikani ketan parle point, surat, gujarat, india 395007 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhwani Patel |
Manubhai patel dental college |
Department of prosthodontics crown and bridge including implantology Manubhai Patel Dental College and Hospital, Vadodara, 390011
Vadodara
GUJARAT |
8160490999
dhwani081@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC) FOR RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEEK(polyetheretherketone) full coverage crown |
To evaluate clinical performance of PEEK in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria for 6 months |
| Comparator Agent |
PFM (Porcelain fused to metal) full coverage crown |
To evaluate the clinical performance of PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
2. Patients with endodontically treated maxillary or mandibular 1st or 2nd molar.
3. Antagonist teeth should be present
4. Height abutment teeth should be approximately 3 mm on the buccal and lingual sides after preparation
5. Patients with good oral hygiene
6. Absence of parafunctional habits
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the clinical performance of PEEK and PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria.
2. To evaluate and compare the periodontal status of PEEK and PFM using Russel’s periodontal index
|
baseline = T0
After 3 Months = T1
After 6 Months = T2
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare the clinical performance of PEEK and PFM in terms of anatomical contour, marginal integrity, Restoration staining, Color match, Surface texture using the modified Ryge’s criteria.
2. To compare the periodontal status of PEEK and PFM using Russel’s periodontal index
|
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|
This
will be an in-vivo study. 70 patients (35 per group) undergoing fixed dental
prosthesis treatment will be selected for the study. The study protocol will
be verbally explained and a consent form will be obtained from the patients
and only those willing are going to include in the study.Complete case history shall be recorded followed
by clinical examination. Then, intra oral pre-operative photographs will be
taken. Then a silicone putty index will be made for standardization of the
tooth preparation.Standardized teeth preparations will be done
with the aid of orientation grooves on the occlusal and lingual surfaces to
produce 1 mm equi-gingival deep chamfer finish line with 1-1.5 mm axial
reduction with round and taper diamond bur (TR-11) and 1.5-2 mm occlusal
reduction with torpedo bur (no.171). Orientation grooves on buccal surfaces to
produce 1 mm equi-gingival shoulder finish line with 1-1.5 mm axial reduction
with flat end taper bur (TF-12). Proximal reduction will be done with short
needle diamond bur. All sharp line angles that might serve as a point for
stress concentration were rounded. Finishing of shoulder margin will be done
with end cutting bur (no.957). Functional cusp bevel will be performed with 45o
to the long axis of the functional cusps with Round and taper bur (TR-12) bur.A retraction cord (Prime Cord – 00) will be used
to allow accurate impression making. Polyvinyl siloxane (PVS) Addition silicon
(Flexceed Kit) will be used for making final impression in metal stock trays. Fbrication of the PEEK and PFM crowns will be done in the laboratory.
|
All the crowns will be luted
adhesively with resin cement (3M RelyX Luting 2 Resin modified GIC) according
to manufacturer’s instructions and post operative instructions are given.Follow up sessions Recall examinations will be performed
to all patients after on the day of 1 week (Baseline), 3 months, 6 months. During the examination, direct clinical
evaluation will be performed by the outcome assessors. using modified Ryge criteria for retention, marginal
integrity, colour matching, marginal discoloration, secondary caries, surface
texture, wear-anatomic form and Periodontal status by using Russel’s
Periodontal Index.
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