| CTRI Number |
CTRI/2026/02/104522 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Checking if the gums react differently to two types of dental crowns — PEEK and zirconia — by measuring IL1beta,a substance linked to inflammation."
|
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Scientific Title of Study
|
COMPARATIVE EVALUATION OF IL-1 beta LEVELS IN GINGIVAL CREVICULAR FLUID AROUND CAD - CAM FABRICATED PEEK CROWNS AND POLISHED ZIRCONIA CROWNS - AN IN VIVO 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 |
Tadu konya |
| Designation |
junior resident |
| Affiliation |
All india institute of medical sciences |
| Address |
second floor department of prosthodontics, centre of dental education and research, All india institute of medical sciences, sri aurobindo marg, Ansari nagar, New delhi
South
DELHI
110029
India |
| Phone |
8131848112 |
| Fax |
|
| Email |
tadukonya3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun kumar N |
| Designation |
Assistant proffesor |
| Affiliation |
All india institute of medical sciences |
| Address |
second floor department of prosthodontics, centre of dental education and research, All india institute of medical sciences, sri aurobindo marg, Ansari nagar, New delhi
South
DELHI
110029
India |
| Phone |
9985203202 |
| Fax |
|
| Email |
drarunaiimsdelhi@gmaill.com |
|
Details of Contact Person
Public Query
|
| Name |
Tadu konya |
| Designation |
junior resident |
| Affiliation |
All india institute of medical sciences |
| Address |
second floor department of prosthodontics, centre of dental education and research, All india institute of medical sciences, sri aurobindo marg, Ansari nagar, New delhi
South
DELHI
110029
India |
| Phone |
8131848112 |
| Fax |
|
| Email |
tadukonya3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tadu konya , JUNIOR RESIDENT,Department of prosthodontics,Centre for dental education and research , AIIMS,110029 |
|
|
Primary Sponsor
|
| Name |
tadu konya |
| Address |
second floor department of prosthodontics, All india institute of medical sciences, ansari nagar east, sri aurobindo marg, new delhi,110029. |
| 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 Tadu konya |
centre of dental education and research |
second floor department of prosthodontics, room no:208, centre of dental education and research, All india institute of medical sciences, sri aurobindo marg, Ansari nagar, New delhi
South
DELHI |
08131848112
tadukonya3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute of ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients requiring crown on first molars bilaterally. |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEEK CROWN |
To evaluate the level of IL-1 beta in gingival crevicular fluid (GCF) before before tooth preparation (baseline) and after the cementation of full coverage of PEEK crown on mandibular posterior tooth at 1 month and 3 months interval.
|
| Comparator Agent |
POLISHED ZIRCONIA CROWN |
To evaluate the level of IL-1 beta in gingival crevicular fluid (GCF) before tooth preparation (baseline) and after the cementation of full coverage of polished zirconia crown on mandibular posterior tooth at 1 month and 3month interval. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring bilaterally posterior mandibular complete crowns. Teeth selected for Permanent CAD/CAM crowns preparation should be restorable with a minimum crown to root ratio of at least 1:1.
2. Patients with good oral hygiene and periodontal status.
3. Patients with full complement of teeth (excluding 3rd molars).
4. Patients who will be available for the required follow up period.
5. Patients giving positive informed consent.
6. Patients with plaque index less than 15 percent, bleeding index less than 10 percent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with developmental defects of enamel and dentin.
2.Patients with systemic disease (e.g, diabetic mellitus, hypertension, cancer, Sjogren’s syndrome etc.)
3. Habitual tobacco smokers.
4. Untreated gingival or periodontal disease
5. Parafunctional habits like bruxism, clenching.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of PEEK crown and polished zirconia crown on IL-1 beta levels in gingival crevicular fluid (GCF) on mandibular posterior teeth on both side. |
to evaluate and compare IL1Beta at baseline,1 month and 3 month after tooth prepration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
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Brief Summary
|
Fixed dental prostheses aim to replace missing teeth while maintaining periodontal health, function and aesthetics. Due to increasing aesthetic demands and concerns about the biocompatibility of metal alloys, all-ceramic crowns -especially zirconia- highly popular. Zirconia offers excellent strength, biocompatibility, soft tissue response, and anti-microbial properties. Polyetherethrketone (PEEK), a member of PEAK family, has recently emerged as a promising alternative crown material. It has good stress modulation, minimal abrasion, stable color, making it a potential substitute of zirconia crowns. Restorative materials may influence periodontal tissues as well as gingival crevicular fluid (GCF). As GCF contains several inflammatory biomarkers such as interleukin-1 beta, interleukin-6, interleukin-8, tumor necrosis factor-alpha and matrix metalloproteinase-8, which are indicators of periodontal inflammation and tissue degradation products from restorative materials. There are numerous studies have explored gingival biomarkers levels in relation to various permanent crowns, there is limited research on how PEEK crowns influence Gingival inflammation and biomarker expression. Therefore, this study is designed to study the effect of PEEK crowns fabricated using CAD-CAM on periodontal health.
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