Periapical PeriodontitisNCT04373018
Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.
A study testing Sodium hypochlorite, Chlorhexidine and Chlorhexidine + Hydrogen peroxide in people with Periapical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Sodium hypochlorite, Chlorhexidine and Chlorhexidine + Hydrogen peroxide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2019to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All patients over 18 years of age.
- Mature permanent mandibular molars.
- A radiographic evidence of periapical radiolucency (minimum size > 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.
Who cannot join
- Diabetics, immunocompromised patients, pregnant females, any systemic disease.
- Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.
- Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis.
- Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.
- Teeth those are not suitable for rubber dam isolation.
- Primary teeth.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS, Rohtak
Rohtak, Haryana
Dr Vinay Kumar, 8901149107, 29vinaykr@gmail.com
Anshu Yadav, 9050522830, anshuyadav99@gmail.com
About this study
Official title: Comparative Evaluation of Clinical and Radiographic Outcome by Using Three Different Irrigants, Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) and Combination of CHX+H2O2 in Primary Endodontic Treatment
This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).
Read the detailed description
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure and its associated risks and benefits. Patients randomly allocated to one of the three study groups Sodium hypochlorite (NaOCl), Chlorhexidine (CHX) and combination of (CHX+H2O2). All three irrigants will be used according to standard protocol during biomechanical preparation. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1year.
- Conditions
- Periapical Periodontitis
- Being tested
- Sodium hypochlorite, Chlorhexidine, Chlorhexidine + Hydrogen peroxide
- Keywords
- Sodium hypochlorite, Chlorhexidine, Hydrogen peroxide
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochloriteProcedure or surgery
Sodium hypochlorite irrigant will be used during biomechanical preparation.
ChlorhexidineProcedure or surgery
Chlorhexidine irrigant will be used during biomechanical preparation.
Chlorhexidine + Hydrogen peroxideProcedure or surgery
Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.
| Study group | Role | What they receive |
|---|---|---|
| Sodium hypochlorite | Active comparator | Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation. Receives: Procedure: Sodium hypochlorite |
| Chlorhexidine | Active comparator | Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation. Receives: Procedure: Chlorhexidine |
| Chlorhexidine + Hydrogen peroxide | Experimental | Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation. Receives: Procedure: Chlorhexidine + Hydrogen peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm .
Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.
Measured: Base line to 1 year.
Secondary outcomes (2)
Radiographic success
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI)
Score Description
- Normal Periapical structure
- Small changes in bone structure
- Changes in bone structure with some mineral loss
- Periodontitis with well defined radiolucent area
- Severe periodontitis with exacerbating features
Measured: Baseline to 1 year
Pain assessment
Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Dec 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anshu Yadav, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373018
- Sponsor's protocol ID
- anshuyendo
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Clinical and Radiographic Outcome by Using Three Different Irrigants, Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) and Combination of CHX+H2O2 in Primary Endodontic Treatment
- ClinicalTrials.gov ID
- NCT04373018
- Acronym / sponsor ID
- anshuyendo
- Conditions
- Periapical Periodontitis
- Keywords
- Sodium hypochlorite, Chlorhexidine, Hydrogen peroxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 4 May 2020 (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.
This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).
Detailed description
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure and its associated risks and benefits. Patients randomly allocated to one of the three study groups Sodium hypochlorite (NaOCl), Chlorhexidine (CHX) and combination of (CHX+H2O2). All three irrigants will be used according to standard protocol during biomechanical preparation. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium hypochlorite | Active comparator | Procedure: Sodium hypochloriteProcedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation. |
| Chlorhexidine | Active comparator | Procedure: ChlorhexidineProcedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation. |
| Chlorhexidine + Hydrogen peroxide | Experimental | Procedure: Chlorhexidine + Hydrogen peroxideProcedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients over 18 years of age.
- Mature permanent mandibular molars.
- A radiographic evidence of periapical radiolucency (minimum size > 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.
Key exclusion criteria (6 listed)
- Diabetics, immunocompromised patients, pregnant females, any systemic disease.
- Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.
- Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis.
- Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.
- Teeth those are not suitable for rubber dam isolation.
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 |
|---|---|---|
| Sodium hypochloriteSodium hypochlorite irrigant will be used during biomechanical preparation. | Procedure or surgery | Sodium hypochlorite |
| ChlorhexidineChlorhexidine irrigant will be used during biomechanical preparation. | Procedure or surgery | Chlorhexidine |
| Chlorhexidine + Hydrogen peroxideChlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation. | Procedure or surgery | Chlorhexidine + Hydrogen peroxide |
Primary outcome
Clinical success
Time frame: Base line to 1 year.
Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm . Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.
2 secondary outcomes
Radiographic success
Time frame: Baseline to 1 year
Pain assessment
Time frame: Baseline to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
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Necrotic Pulps With no Apical Periodontitis
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. This study is not recruiting at the moment.
Anshu Yadav 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 Sodium hypochlorite, Chlorhexidine and Chlorhexidine + Hydrogen peroxide in people with Periapical Periodontitis, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anshu Yadav (9050522830, anshuyadav99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: Base line to 1 year.). 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 4 May 2020.