The aim of this study is to correlate time to achieve haemostasis and concentration of IL-8 in pulpal blood to the outcome of partial pulpotomy after 3 and 6 months follow up.
- Conditions
- Pulpitis,
- Registration Number
- CTRI/2023/06/054485
- Lead Sponsor
- Dr Saada Sulaiman
- Brief Summary
The proposed study shall be conducted in the Department of Conservative Dentistry & Endodontics, at Maulana Azad Institute of Dental Sciences, New Delhi on patients referred to the department for the management of their symptomatic carious permanent molar teeth.
A written informed consent (ANNEXURE II) will be obtained from all patients prior to procedure. A systematic approach of history taking, clinical and radiographic examination and pulp sensibility assessment (cold and EPT) will be done to formulate an appropriate diagnosis.
**A.** **Preparation of operative site**
Local anaesthesia will be induced by the administration of 2% lignocaine with 1:80,000 epinephrine. Calculus and debris will be removed from the tooth surface and subsequently isolated with a rubber dam. The tooth surface will be disinfected with gauze soaked in 5% sodium hypochlorite (NaOCl) prior to caries excavation.
Teeth that will meet the inclusion criteria will be treated with partial pulpotomy as per standardised protocol.
**B.** **Collection of pulpal blood sample**
The cavity will be prepared using a sterile high-speed round bur under water coolant, whereas caries excavation will be performed using a slow-speed round bur. Haemorrhage on entering the pulp chamber confirmed the clinical diagnosis of a vital pulp. 100μL of blood from the exposed surface of the pulp was collected with a micropipette.
In addition, pulpal blood samples will also be collected from 10 non-carious teeth with a diagnosis of normal pulp and periapical tissue that required intentional root canal treatment for prosthetic reasons will also be recruited in the study as controls for quantification of IL-8 in the healthy pulp.
**C.** **Transportation and Storage of blood sample**
The pulpal blood samples will be immediately transferred from the micropipette to the Eppendorf tube
The samples will be stored at -80 ºC at the institute until it is transported to biochemistry laboratory for analysis. IL-8 assay will be done using ELISA.
**A.** **Partial Pulpotomy procedure**
Approximately 2-3 mm of pulpal tissue underneath the exposure site will be amputated using a sterile high-speed round bur. The pulp wound will be flushed with 5ml of 2.5%-3% sodium hypochlorite and the bleeding will be controlled with a sterile cotton pellet moistened with 2.5%-3% sodium hypochlorite for 5 minutes and will be repeated if required up to 15 minutes. Time to achieve haemostasis will be recorded using a stopwatch by another investigator.
If the bleeding cannot be controlled within 15 minutes, the treated tooth will be considered a failure and excluded from the study and further treated by full pulpotomy or root canal treatment.
Biodentine will be mixed according to manufacturers’ instructions and then placed in a 2-3 mm thick layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. After 12 min of waiting for initial setting, a 2-3 mm layer of RMGIC will be placed over the Biodentine and light-cured for 20 seconds. The remaining cavity will be selectively etched with 37% phosphoric acid for 30 seconds and rinsed. The bonding agent will be applied to the cavity with a microbrush brush, agitated for 20 seconds, and light-cured. The cavity will be restored with posterior composite resin and an immediate postoperative radiograph will be taken as a baseline data for further future evaluation.
**B.** **Follow up assessment**
Patients will be called up for clinical (visual inspection, mobility testing, and pulp testing) and radiographic examination after 3 months and 6 months.
Clinical success criteria consists of :
· Absence of spontaneous pain and pain during mastication,
· Absence of swelling, sinus tract and fistula
· Negative response to apical palpation and axial percussion.
Radiographic success criteria consists of:
· No periapical or furcation changes.
· Absence of internal and/or external root resorption.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 135
- < 45 years of age non-contributory medical history Deeply carious permanent molar with a preoperative provisional diagnosis of symptomatic irreversible pulpitis.
- History of spontaneous pain and nocturnal pain which aggravates on lying down.
- No history and signs of sinus tract, pus exudate, fistula, clinical swelling.
- Spontaneous pain and/or with sharp and lingering pain upon cold testing using Endo-Ice.
- Restorable tooth with probing pocket depth (<3mm) Tooth mobility within normal limits Complete caries excavation would likely result in pulpal exposure.
- The radiolucent caries penetrating the entire thickness of the dentine (extremely deep caries).
- Absence of periapical or furcation changes in the radiograph.
- 1)Unexposed pulp after complete caries excavation.
- 2)Uncontrolled pulpal haemorrhage during the procedure lasting more than 15 minutes.
- 3)Absence of bleeding after pulp exposure; the pulp is judged as necrotic or partially necrotic.
- 4)Tooth showing negative response to cold testing or presence of sinus tract or swelling.
- 5)Non-restorable teeth with cracks or subgingival caries, associated sinus or swelling.
- 6)Tooth with poor periodontal support.
- 7)Prominent radiolucency at the furcation or periapical regions.
- 8)Presence of Immature root apices/ apical resorption.
- 9)Presence of internal or pathologic external root resorption, calcification or pulp canal obliteration.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mobility testing 3 months and 6 months pulp testing 3 months and 6 months Radiographic outcome: 3 months and 6 months No periapical or furcation changes 3 months and 6 months Absence of internal and/or external root resorption 3 months and 6 months correlation between pulpotomy outcome and time to achieve pulpal haemostasis. 3 months and 6 months Clinical examination: 3 months and 6 months visual inspection 3 months and 6 months
- Secondary Outcome Measures
Name Time Method levels of IL-8 in pulpal blood and outcome of pulpotomy 3 months and 6 months
Trial Locations
- Locations (1)
Maulana azad institute of dental sciences
🇮🇳Central, DELHI, India
Maulana azad institute of dental sciences🇮🇳Central, DELHI, IndiaDr Saada SulaimanPrincipal investigator09947124321ime.saada@gmail.com