| CTRI Number |
CTRI/2024/01/061399 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of two crown materials on gum health at various time interval. |
|
Scientific Title of Study
|
To evaluate and compare the effect of translucent zirconia and lithium disilicate crown on IL- 6 and TNF- levels in gingival crevicular fluid GCF at various time intervals a split-mouth comparative pilot 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 |
Talke Sonali Sanjay |
| Designation |
Junior Resident |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9284208020 |
| Fax |
|
| Email |
sonalitalke66199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Talke Sonali Sanjay |
| Designation |
Junior Resident |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, New Delhi-110029
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9284208020 |
| Fax |
|
| Email |
sonalitalke66199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Talke Sonali Sanjay, Junior Resident, Department of Prosthodontics, Centre for Dental Education and
Research, AIIMS
|
|
|
Primary Sponsor
|
| Name |
Talke Sonali Sanjay |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
Aurobindo Garg, Ansari Nagar East, Ansari Nagar, 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 Sonali Talke |
Centre for Dental Education and Research ,AIIMS |
2 nd Floor, Department
of Prosthodontics.
New Delhi
DELHI |
9284208020
sonalitalke66199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lithium disilicate crown |
evaluate the level of IL-6 and TNF- α in gingival crevicular fluid (GCF) before tooth preparation (baseline) and after the cementation of full coverage lithium disilicate crown on mandibular 1st molar at 1 week ,12 weeks, and 24 weeks, time intervals. |
| Intervention |
translucent zirconia crown |
evaluate the level of IL-6 and TNF-α in gingival crevicular fluid (GCF) before tooth preparation (baseline) and after the cementation of full coverage translucent zirconia crown on mandibular 1st molar at 1 week ,12 weeks, and 24, weeks’ time intervals |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring bilateral posterior mandibular first molar complete crowns.
2.Teeth selected for crown preparation should be restorable with a minimum crown to root
ratio of at least 1:1.
3. Restored tooth should be healthy and free from plaque and any inflammation.
4. Good oral hygiene and periodontal status with overall gingival indices criteria should be of
15% or less. (22)
12
5. Full complement of teeth (excluding 3rd molars).
6. Patients who will be available for the required follow up period.
7. Patients giving positive informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant and breastfeeding women.
2. Systemic disease (e.g., Diabetes mellitus, hypertension, cancer, sjogren’s syndrome,
mental retardation etc).
3. Patient on medication like drug related gingival hyperplasia (e.g., Phenytoin, sodium
valproate, and cyclosporine), antibiotics, steroids and non-steroidal anti-inflammatory
drugs within 3 months.
4. Habitual tobacco smokers.
5. Untreated gingivitis and periodontal disease.
6. A poor oral hygiene patient will be excluded from this study.
|
|
|
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 |
To evaluate & compare the effect of translucent zirconia & lithium disilicate crown on IL-6 & TNF-α levels in gingival
crevicular fluid (GCF) on
mandibular first molar on both sides. |
before tooth
preparation (baseline) & 1 week after the
cementation of full-coverage translucent
zirconia & lithium disilicate crown on
mandibular first molar. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the effect of translucent zirconia & lithium disilicate crown on IL-6 & TNF-α levels in gingival
crevicular fluid (GCF) on
mandibular first molar on both sides. |
12 weeks & 24 weeks after the
cementation of full-coverage translucent
zirconia & lithium disilicate crown on
mandibular first molar |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
22/01/2024 |
| 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
|
|
Brief Summary
|
Different crown materials have been known to affect the health of the periodontium. Dental restorations are in close contact with the oral tissues, and although systemic side effects are rarely observed, yet local inflammatory reaction or hypersensitivity may be observed sometimes. Gingival crevicular fluid (GCF) is a physiologic transudate present in a healthy gingival crevice in a small amount that increases during periodontal inflammation and becomes an inflammatory exudate. It is a promising diagnostic and prognostic fluid with many advantages such as site-specific, non-invasiveness and contains a wide variety of microbial and host mediators like pro-inflammatory cytokines such as IL-1 b, IL-6, IL-8, TNF-α etc. Periodontal inflammation is characterized by well-orchestrated process of host defence through leukocyte recruitment and monocyte activation. These cells have been known to release pro-inflammatory mediators and cytokines (IL-1, IL-6, and Tumour necrosis factor alpha (TNF-α) in gingival crevicular fluid (GCF), that contribute to the inflammation. TNF-α is responsible for activation of cytokines and initiates the process of inflammation. Macrophages and T-cells secrete TNF-α, which play an important role in early induction of periodontal inflammation. Similarly, Interleukin-6 (IL-6) also activates localized immune cells and causes gingivitis and periodontal tissues destruction. Furthermore, TNF-α may synergistically stimulate human gingival fibroblasts to enhance IL6 secretion. Elevation of both IL-6 and TNF-α causes periodontal and gingival breakdown via disturbances in lipid metabolism of cells. Increased IL-6 levels are reported in periodontitis and a significant decrease in its level following periodontal therapy indicates its role as an early disease onset biomarker for periodontal inflammation has been established. Therefore, increased IL-6 and TNF-α in seen with early inflammatory conditions like marginal gingivitis and their levels further increases in periodontal breakdown. Translucent zirconia and lithium disilicate are indirect restorative materials that are commonly used because of their high aesthetic properties, mechanical properties, flexural strength, durability and biocompatibility.Therefore, this study has been designed to evaluate and compare the effect of translucent zirconia and lithium disilicate crown on gingival biomarkers (IL-6 and TNF- α) levels in gingival crevicular fluid (GCF) at various time intervals. |