| CTRI Number |
CTRI/2025/10/095756 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare gum health markers between two types of temporary crowns made using different techniques. |
|
Scientific Title of Study
|
Comparative evaluation of IL-6 and IL-1 beta levels in Polymethyl Methacrylate (PMMA) milled and 3D printed provisional crowns: A split-mouth 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 |
Krishna vk |
| Designation |
Junior resident |
| Affiliation |
CDER,AIIMS NEW DELHI. |
| Address |
Second nd Floor, Department of Prosthodontics, CDER,AIIMS NEW DELHI-110029 .
India
New Delhi
DELHI
110029
India |
| Phone |
9400598795 |
| Fax |
|
| Email |
vkkrishna97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena jain |
| Designation |
Head of department of prosthodontics. |
| Affiliation |
CDER,AIIMS NEW DELHI. |
| Address |
2 nd Floor,Department of Prosthodontics, CDER,AIIMS NEW DELHI-110029 .
India
New Delhi
DELHI
110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
krishna vk |
| Designation |
Junior resident |
| Affiliation |
CDER,AIIMS NEW DELHI. |
| Address |
2 nd Floor, Department of Prosthodontics, CDER,AIIMS NEW DELHI-110029 .
New Delhi
DELHI
110029
India |
| Phone |
9400598795 |
| Fax |
|
| Email |
vkkrishna97@gmail.com |
|
|
Source of Monetary or Material Support
|
| CDER,AIIMS NEW DELHI.PINCODE 110029 |
|
|
Primary Sponsor
|
| Name |
krishna vk |
| Address |
2nd floor,department of prosthodontics,Centre for dental education and research,AIIMS,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 krishna vk |
Centre for dental education and research |
2 nd Floor, Department of Prosthodontics, CDER,AIIMS NEW DELHI-110029 .
India
New Delhi
DELHI |
09400598795
vkkrishna97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,AIIMS |
Submittted/Under Review |
| Institutional ethics committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K03||Other diseases of hard tissues ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
polymethyl methacrylate milled crown |
evaluate the level of IL 6 and IL 1 beta in gingival crevicular fluid before tooth preparation and after cementation of provisional polymethyl methacrylate crown fabricated by CAD CAM milling on mandibular first molar at 2 week and 6 week.Here temporary crown is fabricated by milling technique. |
| Comparator Agent |
polymethyl methacrylate 3D printed crown |
evaluate the level of IL 6 and IL 1 beta in gingival crevicular fluid before tooth preparation and after cementation of provisional polymethyl methacrylate crown fabricated by CAD CAM 3D printing in mandibular first molar at 2 week and 6 week.Here temporary crown is fabricated by 3D printing technique. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring bilateral posterior mandibular complete crowns.
2.Teeth selected for temporary CAD/CAM milled and printed crown preparation should be restorable with a minimum crown to root ratio of at least 1:1.
3.Patients with good oral hygiene and periodontal status.
4.Patients with full complement of teeth .
5.Patients who will be available for the required follow up period.
6.Patients giving positive informed consent.
7.Patients with plaque index less than15%,bleeding index less than 10%.
|
|
| 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 or chewers.
4.Untreated gingival or periodontal disease
5.Parafunctional habits like bruxism, clenching.
6.Temporomandibular joint disorders.
7.Patients with fluorosis, calcium metabolic disorders, osteoporosis.
8.Patients having malocclusion .
9.Pregnant and breastfeeding women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1). To evaluate the level of IL-6 in gingival crevicular fluid(GCF) just before tooth preparation(baseline) and after cementation of CAD/CAM milled and 3D printed PMMA resin provisional crown on mandibular first molar at 2 week and 6 week .
2). To evaluate the level of IL-1 beta in gingival crevicular fluid(GCF) just before tooth preparation(baseline) and after cementation of CAD/CAM milled and 3D printed PMMA resin provisional crown on mandibular first molar at 2 week and 6 week.
|
before preparation,after2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1). To compare the level of IL-6 in gingival crevicular fluid before tooth preparation (baseline)and after cementation of CAD-CAM milled and 3D printed provisional restoration on mandibular first molar at 2week and 6 week interval.
2). To compare the level of IL-1 beta in gingival crevicular fluid before tooth preparation (baseline)and after cementation of provisional restoration on mandibular first molar at 2week and 6 week interval.
|
before preparation,after2 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
18/10/2025 |
| 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="2"
Months="0"
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
|
|
Brief Summary
|
Gingival crevicular fluid contains various biomarkers, which are associated with periodontal inflammation and tissue degradation.
Among the various biomarkers present in GCF, pro-inflammatory cytokines such as
Interleukin-6 and Interleukin-1 beta play a pivotal role in the
host immune response and appears early in GCF.Numerous
studies have explored gingival biomarker levels in relation to permanent
crowns, there is limited research on how provisional crowns influence gingival
inflammation and biomarker expression.Literature is scanty on effect of provisional
crowns fabricated using milled or PMMA on periodontal health. Therefore this
study is designed. |