Pulp Disease, DentalNCT06836882
Effect of Cavity Disinfectants on Post Operative Pain & Success of Partial Caries Removal
A study testing Selective caries removal, Selective caries removal with NaOCl and Selective caries removal with CHX in people with Pulp Disease, Dental, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To investigate The Effect of Sodium hypochlorite and Chlorhexidine as cavity Disinfectants on the post operative pain and Success of Partial Caries Removal in deep carious lesion with moderate pulpitis in permanent teeth Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Selective caries removal, Selective caries removal with NaOCl and Selective caries removal with CHX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteIndia
- Study dates
- 23 May 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient should be ≥18 years of age.
- Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of moderate pulpitis.
- Radiographic finding of periapical index (PAI) score ≤2.
- Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit)
Who cannot join
- Presence of vertical root fracture Presence of root perforations ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists) Presence of root resorption Combined endodontic-periodontic lesions. Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Pgids Rohtak
Haryāna
PARICHAY SINGHAL, PG STUDENT, 9717710642, parichaysinghal11@gmail.com
SHWETA MITTAL, MDS, 9255596960
About this study
Official title: The Effect of Sodium Hypochlorite and Chlorhexidine as Cavity Disinfectants on the Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesion With Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
To investigate The Effect of Sodium hypochlorite and Chlorhexidine as cavity Disinfectants on the post operative pain and Success of Partial Caries Removal in deep carious lesion with moderate pulpitis in permanent teeth
Read the detailed description
Study Design: Intervention Research Question : To investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion P (Population) - Mature Permanent Mandibular molars with deep carious lesion involving inner two third of dentine I (Intervention) - - Partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant..
C (Comparison) - Partial caries removal using saline as cavity disinfectant. O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
-To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.
- Conditions
- Pulp Disease, Dental
- Being tested
- Selective caries removal, Selective caries removal with NaOCl, Selective caries removal with CHX
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective caries removalProcedure or surgery
Selective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group.
Selective caries removal with NaOClProcedure or surgery
elective caries removal followed by cavity disinfection with NaOCl
Selective caries removal with CHXProcedure or surgery
elective caries removal followed by cavity disinfection with CHX
| Study group | Role | What they receive |
|---|---|---|
| Pt receiving SCR treatment | Active comparator | No disinfectant solution was applied (control group). Receives: Procedure: Selective caries removal |
| Pt receiving SCR followed by disinfection with NaOCl | Experimental | the cavity was disinfected with 2.5% sodium hypochlorite Receives: Procedure: Selective caries removal; Procedure: Selective caries removal with NaOCl |
| Pt receiving SCR followed by disinfection with Chlorhexidine | Experimental | The cavity was disinfected with 2% CHX. Receives: Procedure: Selective caries removal; Procedure: Selective caries removal with CHX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success criteria
No history of spontaneous pain or discomfort except for the initial days after treatment.
No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Measured: 12 months
Radiographic success criteria
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.
Periapical Index score 1 or 2 according to OrstavicKet al.
Measured: 12mnths
Secondary outcomes (1)
Pain assesment
Patients will be informed that they may experience pain in the days after treatment and will be instructed to record their pain at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, to be submitted after 1 week.
They will be instructed to use analgesics (Ibuprofen 400 mg every 6-8 h), if needed for pain relief. They will be requested to note down the details of analgesic intake on the pain form regarding the number of doses required, timing of the dose and whether it provided adequate pain relief or not (yes/no) Visual analogue scale (VAS) from 0 to 100 will be used to record preoperative and post -operative pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start23 May 2024
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Sanjay Tewari, MDS, Principal investigator, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836882
- Sponsor's protocol ID
- shweta mittal
- Status last verified
- Feb 2025
- First submitted
- 9 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Hypochlorite and Chlorhexidine as Cavity Disinfectants on the Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesion With Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06836882
- Acronym / sponsor ID
- shweta mittal
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate The Effect of Sodium hypochlorite and Chlorhexidine as cavity Disinfectants on the post operative pain and Success of Partial Caries Removal in deep carious lesion with moderate pulpitis in permanent teeth
Detailed description
Study Design: Intervention Research Question : To investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion P (Population) - Mature Permanent Mandibular molars with deep carious lesion involving inner two third of dentine I (Intervention) - - Partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant..
C (Comparison) - Partial caries removal using saline as cavity disinfectant. O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
-To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pt receiving SCR treatment | Active comparator | Procedure: Selective caries removalNo disinfectant solution was applied (control group). |
| Pt receiving SCR followed by disinfection with NaOCl | Experimental | Procedure: Selective caries removal, Procedure: Selective caries removal with NaOClthe cavity was disinfected with 2.5% sodium hypochlorite |
| Pt receiving SCR followed by disinfection with Chlorhexidine | Experimental | Procedure: Selective caries removal, Procedure: Selective caries removal with CHXThe cavity was disinfected with 2% CHX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient should be ≥18 years of age.
- Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
- Tooth should give positive response to pulp sensibility testing.
- Clinical diagnosis of moderate pulpitis.
- Radiographic finding of periapical index (PAI) score ≤2.
Key exclusion criteria (1 listed)
- Presence of vertical root fracture Presence of root perforations ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists) Presence of root resorption Combined endodontic-periodontic lesions. Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective caries removalSelective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group. | Procedure or surgery | Pt receiving SCR followed by disinfection with Chlorhexidine, Pt receiving SCR followed by disinfection with NaOCl, Pt receiving SCR treatment |
| Selective caries removal with NaOClelective caries removal followed by cavity disinfection with NaOCl | Procedure or surgery | Pt receiving SCR followed by disinfection with NaOCl |
| Selective caries removal with CHXelective caries removal followed by cavity disinfection with CHX | Procedure or surgery | Pt receiving SCR followed by disinfection with Chlorhexidine |
Primary outcome
Clinical success criteria
Time frame: 12 months
No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Radiographic success criteria
Time frame: 12mnths
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to OrstavicKet al.
1 secondary outcome
Pain assesment
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Sanjay Tewari, MDS principal investigator
PGIDS Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective caries removal, Selective caries removal with NaOCl and Selective caries removal with CHX in people with Pulp Disease, Dental, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shweta Mittal (9255596960, shwetagoelendo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success criteria (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.