Apical PeriodontitisNCT03711942
Comparison of Healing of Apical Periodontitis in Periodontally Diseased and Healthy Patients.
A study testing Intra orifice barrier and Base in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial summary
Periodontal health may jeopardize the success of endodontic treatment.Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection is known to contribute in worsening of periodontal health by promoting marginal bone loss and… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Intra orifice barrier and Base
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to 30 Apr 2018
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Permanent mandibular molar with pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test),
- Radiographic evidence of apical periodontitis in the form of periapical radiolucency (minimum size ≥ 2 mm ~ 2 mm),
- Probing Depth of not more than 5mm.
Who cannot join
- Patient with diabetes,
- History of antibiotic intake in past 1 month,
- Presence of any immunocompromised conditions,
- Pregnant women, and
- Root filled and unrestorable teeth
About this study
Periodontal health may jeopardize the success of endodontic treatment.Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection is known to contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation.This study compared the apical healing in healthy and periodontally compromised teeth and evaluated the effect of intra orifice barrier and base in the healing of apical periodontitis.
Read the detailed description
Endodontic treatment comprises bio-mechanical preparation of root canal system, chemical debridement and obturation with inert material. Various prognostic factors like adequacy of root filling, pre-operative size of periapical lesion on radiograph, type and location of teeth, periodontal status of the teeth and coronal restoration may play role in the success of endodontic treatment.
In the presence of defective coronal seal percolation of saliva and microbes may take place causing treatment failure. This assumption has acquired support mainly from various in-vitro studies which has demonstrated penetration of dye /microbe / radioactive tracer along root filling. Marshall and Massler in an in-vitro study using radioisotopes were first to highlight effect of coronal leakage and later Swanson and Madison in a study involving 70 extracted single rooted human teeth showed complete dye penetration throughout obturation material and along the canal walls. Since then there has been a renewed interest in the endodontic community in exploring relation of coronal seal with prognosis of endodontic treatment.
In a retrospective study Ray and Trope concluded that coronal restoration has greater impact on success of endodontic therapy rather than quality of root filling. However, various other epidemiological studies failed to replicate this result. A recent meta-analysis stated that problem of coronal leakage may not be of that clinical significance as demonstrated in various in-vitro studies, though importance of good coronal restoration and good root filling in the success of endodontic treatment can't be denied.
Placing an additional protective barrier in the coronal portion of the root canal has been recommended to minimize microleakage and facilitate healing of apical periodontitis. Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection may also contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation. Similarity between microflora of periodontium and root canal has led to a view that the communication between the two exists, and can potentially affect status of one another. The observations on this issue have been conflicting in nature with some authors reporting pulpal necrosis due to periodontal disease, and others reporting normal teeth regardless of severity of periodontal disease (Zehnder). Stassen et al. in a retrospective study observed more signs of apical periodontitis in teeth with reduced marginal support. They also reported significant influence of coronal extent of obturation on outcome of endodontic treatment in periodontally compromised patients. Significantly less incidence of apical periodontitis was seen where gutta percha was apical to marginal bone as compared to gutta percha being coronal to marginal bone. It is evident that the interrelationship between root canal and periodontium is complicated, and still not fully understood on account of lack of studies exploring the topic So far no prospective clinical trial has investigated the effect of periodontal status on healing of apical periodontitis. Also in absence of a clinical study substantial amount of doubt still persists whether intraorifice barrier can emerge as an effective mean to prevent microleakage in furcation and root canals of a multirooted tooth which because of its anatomical aberrations poses stiff challenge for clinicians. Therefore aim of this study was to determine effect of the periodontal status on periapical healing and to determine effect of intracanal glass ionomer restoration as intraorifice barrier on treatment outcome of apical periodontitis.
Clinical procedure:
After initial periodontal therapy, Standard root canal treatment was done using standard protocol. The canals were prepared with Revo S instrument according to manufacturer instructions and obturation was done using gutta percha. First of all, local anesthesia was administered using 2% lignocaine hydrochloride with epinephrine 1:80,000 (ICPA Health Products Ltd, Ankleshwar, India) and tooth was isolated under rubber dam. Caries excavation was done and access cavity was prepared using carbide burs in high speed hand-piece with copious irrigation. The pulp chamber was debrided and all canal orifices were identified and coronally enlarged with low speed Gates Glidden drills (Mani Inc, Utsunomiya, Tochigi, Japan). Working length was determined using Root ZX apex locator (J. Morita, Irvine, CA) and verified radiographically. After creating glide path with #15 k-file, Revo-S (Micro Mega, Besancon, France) instruments were used in sequence as suggested by manufacturer with a rotational speed of 350 rpm at torque setting of 2.5 Ncm in gentle in-out motion. Irrigation was carried out using 5 mL of a 5.25% Sodium hypochlorite (NaOCl; PrevestDenpro Ltd, Jammu, India) solution between files with 26 gauge side vented needle (Neelkanth Healthcare Pvt. Ltd, Jodhpur, Rajasthan, India). After preparation, the root canals were irrigated with 5 mL 17% EDTA (Canallarge, Ammdent, Mohali, India) for 1 minute to remove smear layer, followed by final irrigation with 5 mL 5.25% NaOCl. The root canal was then dried using paper points and filled with laterally condensed gutta-percha (Meta Biomed Co Ltd, Korea) and zinc oxide eugenol sealer (Dental Products of India Ltd, New Delhi, India). Gutta-percha was cut with a heated instrument and vertically condensed right at the orifice opening of the canals.
The teeth were then randomly sub-divided into 3 experimental groups IOB, Base and Control. In IOB group gutta-percha was removed 3 mm from the coronal portion of the canal with heated plugger, while it was left at the level of orifice in base and control groups. Thereafter, coronal restoration of composite resin was done in all groups. In IOB group orifice was sealed with GIC and base of GIC was applied in both IOB and base group before composite restoration
- Conditions
- Apical Periodontitis
- Being tested
- Intra orifice barrier, Base, Control
- Keywords
- Root canal treatment, intraorifice barrier.
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra orifice barrierProcedure or surgery
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.3mm GP in the orifice was removed and intraorifice barrier and 2mm thick base was given of GIC.
BaseProcedure or surgery
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.2mm thick Base of GIC was applied over the orifice before composite restoration
ControlProcedure or surgery
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.coronal accees upto orifice was restored with composite resin
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy IOB | Active comparator | Intra orifice barrier (IOB) was placed in periodontally healthy molar. Receives: Procedure: Intra orifice barrier |
| Periodontally Healthy Base | Experimental | 2mm thick base was applied in periodontally health teeth. Receives: Procedure: Base |
| Periodontally healthy control | Experimental | coronal access was restored with composite resin without any base. Receives: Procedure: Control |
| Periodontally diseased IOB | Active comparator | Intra orifice barrier (IOB) was placed in periodontally healthy molar Receives: Procedure: Intra orifice barrier |
| Periodontally diseased Base | Active comparator | 2mm thick Base of GIC was applied under composite restoration Receives: Procedure: Base |
| Periodontally diseased control | Active comparator | coronal access was restored with composite resin without any base Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of apical periodontitis
Clinical success as depicted by absence of signs and symptoms, and radiographic success demonstrated by absence of periapical alterations (radiolucency at furcal or periapical region).
Measured: Baseline to one year
Secondary outcomes (1)
Healing of marginal periodontitis
improvement of periodontal parameters like probing depth (in millimeter) and marginal bone height (in millimeter).
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Oct 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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
- NCT03711942
- Sponsor's protocol ID
- Gaurav Endo
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Healing of Apical Periodontitis in Periodontally Diseased and Healthy Patients.
- ClinicalTrials.gov ID
- NCT03711942
- Acronym / sponsor ID
- Gaurav Endo
- Conditions
- Apical Periodontitis
- Keywords
- Root canal treatment, intraorifice barrier.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 19 Oct 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.
Periodontal health may jeopardize the success of endodontic treatment.Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection is known to contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation.This study compared the apical healing in healthy and periodontally compromised teeth and evaluated the effect of intra orifice barrier and base in the healing of apical periodontitis.
Detailed description
Endodontic treatment comprises bio-mechanical preparation of root canal system, chemical debridement and obturation with inert material. Various prognostic factors like adequacy of root filling, pre-operative size of periapical lesion on radiograph, type and location of teeth, periodontal status of the teeth and coronal restoration may play role in the success of endodontic treatment.
In the presence of defective coronal seal percolation of saliva and microbes may take place causing treatment failure. This assumption has acquired support mainly from various in-vitro studies which has demonstrated penetration of dye /microbe / radioactive tracer along root filling. Marshall and Massler in an in-vitro study using radioisotopes were first to highlight effect of coronal leakage and later Swanson and Madison in a study involving 70 extracted single rooted human teeth showed complete dye penetration throughout obturation material and along the canal walls. Since then there has been a renewed interest in the endodontic community in exploring relation of coronal seal with prognosis of endodontic treatment.
In a retrospective study Ray and Trope concluded that coronal restoration has greater impact on success of endodontic therapy rather than quality of root filling. However, various other epidemiological studies failed to replicate this result. A recent meta-analysis stated that problem of coronal leakage may not be of that clinical significance as demonstrated in various in-vitro studies, though importance of good coronal restoration and good root filling in the success of endodontic treatment can't be denied.
Placing an additional protective barrier in the coronal portion of the root canal has been recommended to minimize microleakage and facilitate healing of apical periodontitis. Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection may also contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation. Similarity between microflora of periodontium and root canal has led to a view that the communication between the two exists, and can potentially affect status of one another. The observations on this issue have been conflicting in nature with some authors reporting pulpal necrosis due to periodontal disease, and others reporting normal teeth regardless of severity of periodontal disease (Zehnder). Stassen et al. in a retrospective study observed more signs of apical periodontitis in teeth with reduced marginal support. They also reported significant influence of coronal extent of obturation on outcome of endodontic treatment in periodontally compromised patients. Significantly less incidence of apical periodontitis was seen where gutta percha was apical to marginal bone as compared to gutta percha being coronal to marginal bone. It is evident that the interrelationship between root canal and periodontium is complicated, and still not fully understood on account of lack of studies exploring the topic So far no prospective clinical trial has investigated the effect of periodontal status on healing of apical periodontitis. Also in absence of a clinical study substantial amount of doubt still persists whether intraorifice barrier can emerge as an effective mean to prevent microleakage in furcation and root canals of a multirooted tooth which because of its anatomical aberrations poses stiff challenge for clinicians. Therefore aim of this study was to determine effect of the periodontal status on periapical healing and to determine effect of intracanal glass ionomer restoration as intraorifice barrier on treatment outcome of apical periodontitis.
Clinical procedure:
After initial periodontal therapy, Standard root canal treatment was done using standard protocol. The canals were prepared with Revo S instrument according to manufacturer instructions and obturation was done using gutta percha. First of all, local anesthesia was administered using 2% lignocaine hydrochloride with epinephrine 1:80,000 (ICPA Health Products Ltd, Ankleshwar, India) and tooth was isolated under rubber dam. Caries excavation was done and access cavity was prepared using carbide burs in high speed hand-piece with copious irrigation. The pulp chamber was debrided and all canal orifices were identified and coronally enlarged with low speed Gates Glidden drills (Mani Inc, Utsunomiya, Tochigi, Japan). Working length was determined using Root ZX apex locator (J. Morita, Irvine, CA) and verified radiographically. After creating glide path with #15 k-file, Revo-S (Micro Mega, Besancon, France) instruments were used in sequence as suggested by manufacturer with a rotational speed of 350 rpm at torque setting of 2.5 Ncm in gentle in-out motion. Irrigation was carried out using 5 mL of a 5.25% Sodium hypochlorite (NaOCl; PrevestDenpro Ltd, Jammu, India) solution between files with 26 gauge side vented needle (Neelkanth Healthcare Pvt. Ltd, Jodhpur, Rajasthan, India). After preparation, the root canals were irrigated with 5 mL 17% EDTA (Canallarge, Ammdent, Mohali, India) for 1 minute to remove smear layer, followed by final irrigation with 5 mL 5.25% NaOCl. The root canal was then dried using paper points and filled with laterally condensed gutta-percha (Meta Biomed Co Ltd, Korea) and zinc oxide eugenol sealer (Dental Products of India Ltd, New Delhi, India). Gutta-percha was cut with a heated instrument and vertically condensed right at the orifice opening of the canals.
The teeth were then randomly sub-divided into 3 experimental groups IOB, Base and Control. In IOB group gutta-percha was removed 3 mm from the coronal portion of the canal with heated plugger, while it was left at the level of orifice in base and control groups. Thereafter, coronal restoration of composite resin was done in all groups. In IOB group orifice was sealed with GIC and base of GIC was applied in both IOB and base group before composite restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy IOB | Active comparator | Procedure: Intra orifice barrierIntra orifice barrier (IOB) was placed in periodontally healthy molar. |
| Periodontally Healthy Base | Experimental | Procedure: Base2mm thick base was applied in periodontally health teeth. |
| Periodontally healthy control | Experimental | Procedure: Controlcoronal access was restored with composite resin without any base. |
| Periodontally diseased IOB | Active comparator | Procedure: Intra orifice barrierIntra orifice barrier (IOB) was placed in periodontally healthy molar |
| Periodontally diseased Base | Active comparator | Procedure: Base2mm thick Base of GIC was applied under composite restoration |
| Periodontally diseased control | Active comparator | Procedure: Controlcoronal access was restored with composite resin without any base |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent mandibular molar with pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test),
- Radiographic evidence of apical periodontitis in the form of periapical radiolucency (minimum size ≥ 2 mm ~ 2 mm),
- Probing Depth of not more than 5mm.
Key exclusion criteria (5 listed)
- Patient with diabetes,
- History of antibiotic intake in past 1 month,
- Presence of any immunocompromised conditions,
- Pregnant women, and
- Root filled and unrestorable teeth
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 |
|---|---|---|
| Intra orifice barrierAfter primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.3mm GP in the orifice was removed and intraorifice barrier and 2mm thick base was given of GIC. | Procedure or surgery | Periodontally Healthy IOB, Periodontally diseased IOB |
| BaseAfter primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.2mm thick Base of GIC was applied over the orifice before composite restoration | Procedure or surgery | Periodontally Healthy Base, Periodontally diseased Base |
| ControlAfter primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.coronal accees upto orifice was restored with composite resin | Procedure or surgery | Periodontally diseased control, Periodontally healthy control |
Primary outcome
Healing of apical periodontitis
Time frame: Baseline to one year
Clinical success as depicted by absence of signs and symptoms, and radiographic success demonstrated by absence of periapical alterations (radiolucency at furcal or periapical region).
1 secondary outcome
Healing of marginal periodontitis
Time frame: Baseline to one year
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 19 Oct 2018.
- 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. 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 Intra orifice barrier and Base 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 3 inclusion and 5 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 19 Oct 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?
Healing of apical periodontitis (time frame: Baseline to one 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 19 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.