Apical PeriodontitisNCT03454815
Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth
A study testing Apical patency in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial summary
Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Apical patency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 30 Nov 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mature permanent mandibular first molars
- Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
- Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
- Probing depth < 4mm
Who cannot join
- Non willingness to participate in study
- younger than 18 years of age
- Pregnant, diabetic or immunocompromised
- Prior endodontic treatment of the same tooth
- History of antibiotic use in past one month or requiring antibiotic pre-medication
- unrestorable teeth, fractured or perforated roots, grade 3 mobility
About this study
Official title: Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study
Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.
Read the detailed description
AIM:
- To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth.
- To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency.
Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry \& Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study.
Clinical procedure:
Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle.
In patency group, a #10 K- file was passed 1mm beyond the WL between each instrument change, while in non-patency group it was carried till the WL. In patency group, a final radiograph was taken after completion of preparation, with a #10 file placed 1mm beyond the WL to confirm patency.
After enlargement, the canals were irrigated with 5ml 17% EDTA for 1 min followed by irrigation with 5ml 3% NaOCl. Canals were dried with absorbent paper points and filled with a paste made by mixing Calcium hydroxide powder with 2% Chlorhexidine liquid; and the access cavity restored with intermediate restorative material (IRM). The patient was recalled after 1 week. At the next appointment, the paste was removed with H- files and copious irrigation with 3% NaOCl. Canals were examined under operating microscpe. A final rinse of 5ml 17% EDTA and 5ml 3% NaOCl was done and canals dried with paper points. Canals were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer. After obturation, the cavity was restored with Silver Amalgam/Composite/Full coverage crown. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device; and processed manually. Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period.
Data Gathering Details:
Preoperative and intraoperative data were obtained from patient records. Diagnostic and treatment information was meticulously recorded on a custom designed endodontic treatment form by the operator. Diagnostic and treatment details for each patient were extracted from the records by the principal investigator.
Assessment of treatment outcome:
Treatment outcome was judged on the basis of clinical and radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit
Radiographic success:
Change in Periapical Index (PAI) scores (Orstaviket al) observed at 12-months was noted. Scoring of each tooth was done according to the following five point scale (PAI):
PAI Score Description of radiographic findings
- Normal periapical structures
- Small changes in bone structure
- Changes in bone structure with some mineral loss
- Periodontitis with well-defined radiolucent area
- Severe periodontitis with exacerbating features
Three experienced observers with no knowledge of the treatment protocol independently examined immediate post obturation and follow-up radiographs, mounted side by side, under controlled conditions. The treatment was considered successful only when both clinical and radiographic criteria were met. In multirooted teeth, the worst outcome by root decided the overall outcome for the tooth. In the event of disagreement, the three observers met to discuss their findings and came to an agreement. In the absence of unanimity, the majority decision was taken.
Clinical Success:
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
- Conditions
- Apical Periodontitis
- Being tested
- Apical patency
- Keywords
- Apical Patency, Root Canal Treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical patencyProcedure or surgery
Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation
| Study group | Role | What they receive |
|---|---|---|
| Patency Group | Experimental | apical patency was maintained during chemomechanical preparation Receives: Procedure: Apical patency |
| Non Patency Group | No intervention | Apical patency was not maintained during chemomechanical preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periapical radiolucency
The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
Measured: Baseline to 12-month
Secondary outcomes (1)
Clinical success
Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Measured: Baseline to 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 May 2013
- Primary completion28 Nov 2013
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454815
- Sponsor's protocol ID
- Mayank Arora Thesis
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2018
- Last updated
- 6 Mar 2018
- 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 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study
- ClinicalTrials.gov ID
- NCT03454815
- Acronym / sponsor ID
- Mayank Arora Thesis
- Conditions
- Apical Periodontitis
- Keywords
- Apical Patency, Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 28 Nov 2013 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 6 Mar 2018 (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.
Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.
Detailed description
AIM:
- To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth.
- To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency.
Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry \& Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study.
Clinical procedure:
Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle.
In patency group, a #10 K- file was passed 1mm beyond the WL between each instrument change, while in non-patency group it was carried till the WL. In patency group, a final radiograph was taken after completion of preparation, with a #10 file placed 1mm beyond the WL to confirm patency.
After enlargement, the canals were irrigated with 5ml 17% EDTA for 1 min followed by irrigation with 5ml 3% NaOCl. Canals were dried with absorbent paper points and filled with a paste made by mixing Calcium hydroxide powder with 2% Chlorhexidine liquid; and the access cavity restored with intermediate restorative material (IRM). The patient was recalled after 1 week. At the next appointment, the paste was removed with H- files and copious irrigation with 3% NaOCl. Canals were examined under operating microscpe. A final rinse of 5ml 17% EDTA and 5ml 3% NaOCl was done and canals dried with paper points. Canals were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer. After obturation, the cavity was restored with Silver Amalgam/Composite/Full coverage crown. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device; and processed manually. Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period.
Data Gathering Details:
Preoperative and intraoperative data were obtained from patient records. Diagnostic and treatment information was meticulously recorded on a custom designed endodontic treatment form by the operator. Diagnostic and treatment details for each patient were extracted from the records by the principal investigator.
Assessment of treatment outcome:
Treatment outcome was judged on the basis of clinical and radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit
Radiographic success:
Change in Periapical Index (PAI) scores (Orstaviket al) observed at 12-months was noted. Scoring of each tooth was done according to the following five point scale (PAI):
PAI Score Description of radiographic findings
- Normal periapical structures
- Small changes in bone structure
- Changes in bone structure with some mineral loss
- Periodontitis with well-defined radiolucent area
- Severe periodontitis with exacerbating features
Three experienced observers with no knowledge of the treatment protocol independently examined immediate post obturation and follow-up radiographs, mounted side by side, under controlled conditions. The treatment was considered successful only when both clinical and radiographic criteria were met. In multirooted teeth, the worst outcome by root decided the overall outcome for the tooth. In the event of disagreement, the three observers met to discuss their findings and came to an agreement. In the absence of unanimity, the majority decision was taken.
Clinical Success:
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patency Group | Experimental | Procedure: Apical patencyapical patency was maintained during chemomechanical preparation |
| Non Patency Group | No intervention | –Apical patency was not maintained during chemomechanical preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mature permanent mandibular first molars
- Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
- Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
- Probing depth < 4mm
Key exclusion criteria (6 listed)
- Non willingness to participate in study
- younger than 18 years of age
- Pregnant, diabetic or immunocompromised
- Prior endodontic treatment of the same tooth
- History of antibiotic use in past one month or requiring antibiotic pre-medication
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 |
|---|---|---|
| Apical patencyApical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation | Procedure or surgery | Patency Group |
Primary outcome
Change in periapical radiolucency
Time frame: Baseline to 12-month
The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
1 secondary outcome
Clinical success
Time frame: Baseline to 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Apical patency in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
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 4 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: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in periapical radiolucency (time frame: Baseline to 12-month). 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 6 Mar 2018.