| CTRI Number |
CTRI/2023/02/049408 [Registered on: 02/02/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Inflammatory Biomarker Based validation of Evidence for Vital Pulp Therapy as Alternative to Root Canal Treatment for advanced Dental Caries |
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Scientific Title of Study
|
Inflammatory Biomarker Based Substantiation of Evidence for Performance of Vital Pulp Therapy as
Potential Alternative to Endodontic Treatment using Quantitative light-induced Fluorescence Guided Caries Removal for Management of Symptomatic Carious Mature Teeth (Extremely Deep/Deep Carious Lesion)
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| Trial Acronym |
|
|
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 |
Dr Ruchika Roongta Nawal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Third floor, Department of Conservative Dentistry and Endodontics,
Maulana Azad Institute of Dental Sciences, New Delhi
Central DELHI 110002 India |
| Phone |
9582948894 |
| Fax |
|
| Email |
ruchika.roongta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ruchika Roongta Nawal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Third floor, Department of Conservative Dentistry and Endodontics,
Maulana Azad Institute of Dental Sciences, New Delhi
Central DELHI 110002 India |
| Phone |
9582948894 |
| Fax |
|
| Email |
ruchika.roongta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sudha Yadav |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Third floor, Department of Conservative Dentistry and Endodontics,
Maulana Azad Institute of Dental Sciences, New Delhi
Central DELHI 110002 India |
| Phone |
8010629600 |
| Fax |
|
| Email |
sudhayadav2788@gmail.com |
|
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Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences, New Delhi |
|
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Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences, New Delhi |
| Address |
MAMC Complex, Bahadur Zafar Marg, New Delhi, 110002 |
| Type of Sponsor |
Government 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 |
| Dr Ruchika Roongta Nawal |
Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences |
Third floor, Maulana Azad Institute of Dental Sciences, New Delhi, 110002 Central DELHI |
9582948894
ruchika.roongta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS Institutional Ethical Commitee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Non QLF guided vital pulp therapy |
In the comparator group, carious removal will be done using traditional method with burs and spoon excavator. Partial pulpotomy will be attempted first. If bleeding cannot
be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed.
Approximately 2-3 mm or more of pulpal tissue underneath the exposure site will be removed
(for partial pulpotomy) or the pulp tissue will be removed till the level of canal orifices (for
full pulpotomy), using a sterile high-speed round bur. 2.5-3% sodium hypochlorite will be used for the irrigation of pulpal tissue, and the bleeding will be controlled with 2.5-3%
sodium hypochlorite-moistened cotton pellets.
If the bleeding cannot be controlled within 10 minutes even after performing full pulpotomy, the treated tooth will be excluded from the study and further treated by RCT.
Inflammatory biomarker analysis:
100µL of pulpal blood sample will be collected from all the patients using micropipette after pulpal exposure. The pulpal blood samples will be transferred to numbered Eppendorf cups
(e-cups) , it will be centrifuged at 1.000 x g for 1 min and stored at -80ºC until laboratory processing. Level of inflammatory biomarkers will be assessed using multiplex assay and expressed in assessed in pg/mL. Biodentine will be placed in the cavity and gently packed using a condenser. After 2 weeks, a resin composite restoration will be done. After completing the restoration, a periapical radiograph will be recorded to serve as a baseline for future evaluation.
All the treatment procedure will be done by experienced endodontists under dental operating
microscope using enhance treatment protocol recommended by European society of
Endodontists (ESE).
|
| Intervention |
QLF Guided Vital pulp Therapy |
In the intervention group. After caries removal with burs, prepared cavity will be scanned with Quantitative light induced fluorescence (QLF) device. The infected
dentin indicated by QLF analysis will be further removed. Complete removal of infected dentin will be ensured by scanning prepared cavity again before pulpal exposure. Partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be
performed. Approximately 2-3 mm or more of pulpal tissue underneath the exposure site will be removed
(for partial pulpotomy) or the pulp tissue will be removed till the level of canal orifices (for
full pulpotomy), using a sterile high-speed round bur. 2.5-3% sodium hypochlorite will be
used for the irrigation of pulpal tissue, and the bleeding will be controlled with 2.5-3%
sodium hypochlorite-moistened cotton pellets.
If the bleeding cannot be controlled within 10 minutes even after performing full pulpotomy,
the treated tooth will be excluded from the study and further treated by RCT.
Inflammatory biomarker analysis:
100µL of pulpal blood sample will be collected from all the patients using micropipette after
pulpal exposure. The pulpal blood samples will be transferred to numbered Eppendorf cups
(e-cups) , it will be centrifuged at 1.000 x g for 1 min and stored at -80ºC until laboratory processing. Level of inflammatory biomarkers will be assessed using multiplex assay and expressed in assessed in pg/mL. Biodentine will be placed in the cavity and gently packed using a condenser. After 2 weeks, a resin composite restoration will be done. After completing the restoration, a periapical radiograph will be recorded to serve as a baseline for future evaluation.
The impact of QLF guided caries removal on the outcome of vital pulp therapy will be noted in the follow up visits. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Clinical inclusion criteria:
The age of the patient should be 18 or above
Patient should have non-contributory medical history
Symptomatic permanent mature posterior tooth with deep or extremely deep Class I/II caries with symptoms indicative of irreversible pulpitis
History of Moderate to severe pain
History of spontaneous pain and/or nocturnal pain which aggravates on lying down.
Patient reporting with spontaneous pain and/or with sharp and lingering pain upon
cold testing using Endo-Ice and early exaggerated response with electric pulp testing.
A restorable tooth with probing pocket depth (<3mm) and mobility within normal limits.
Complete caries removal will result in pulpal exposure.
Pulpal bleeding can be arrested with 2.5-3% NaOCl irrigation within 10 minutes after
inflamed pulp amputation.
Radiological inclusion criteria:
Deep or Extremely deep caries
Absence of periapical or furcation changes in the radiograph. |
|
| ExclusionCriteria |
| Details |
Clinical exclusion criteria:
Tooth having unexposed pulp after complete caries removal.
Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.
Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.
Tooth showing negative response to cold testing or presence of sinus tract or swelling.
Radiological exclusion criteria:
Prominent radiolucency at the furcation or periapical regions
Presence of apical resorption
Presence of internal or pathologic external root resorption, calcification, or pulp canal
obliteration. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Clinical and Radiographic success of Vital pulp Treatment at minimum one year follow up
Post operative pain
correlation between Inflammatory markers and pre operative diagnosis
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain assessed using visual analog scale |
i,3,7,14 days |
| Association between level of inflammatory mediators in Pulpal Blood and treatment outcome |
12 months |
| Correlation between level of inflammatory mediators in pulpal blood and preoperative diagnosis |
12 months |
| Effect of Vital pulp treatment on Oral Health Related Quality of Life |
12 months |
|
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Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2023 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ruchika.roongta@gmail.com].
- For how long will this data be available start date provided 25-01-2025 and end date provided 25-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Dental caries affects nearly 3.5 billion people globally. As most patients report in advanced stage, 70% of them need root canal treatment (RCT) for caries management. However, RCT is a destructive procedure resulting in complete removal of vital tissues of the tooth. Vital Pulp Therapy (VPT) has merged as an economical and conservative alternative to RCT. However, at present the main deterrent for VPT to be considered as first line of treatment for carious teeth is lack of high-quality evidence and objective criteria for case selection. Hence, the aim of this prospective clinical study is to evaluate the outcome of vital pulp therapy procedure in symptomatic cariously exposed posterior teeth with Quantitative Light-induced Fluorescence (QLF) assisted caries removal and correlate the level of locally expressed inflammatory biomarkers in pulpal blood with the treatment outcome. The proposed study shall be conducted in the Department of Conservative Dentistry & Endodontics, at Maulana Azad Institute of Dental Sciences, New Delhi on 120 patients referred to the department for the management of their symptomatic carious permanent molar teeth. Informed consent will be obtained from all patients prior to treatment followed by taking history. Patient will be randomly allocated to QLF or Non QLF group. All the treatment procedure will be done by experienced endodontists under dental operating microscope using enhance treatment protocol recommended by European society of Endodontists (ESE). The cavity will be prepared using a sterile high-speed round bur, whereas carious removal will be performed using a slow-speed round bur and a spoon excavator. After caries removal, prepared cavity will be scanned with QLF in QLF group. The infected dentin indicated by QLF analysis will be further removed. Complete removal of infected dentin will be ensured by scanning prepared cavity again before pulpal exposure. In both the Experimental groups, partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed. Patient will be regularly followed up for post operative pain assessment (1,3,7,14 days), clinical and radiographic treatment outcome (Minimum 1 year follow up). |