Apical PeriodontitisNCT03409887
Effect of Intraorifice Barrier on Healing of Apical Periodontitis
A study testing Intraorifice barrier of GIC, Base of GIC and Direct composite restoration in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial summary
Based on various in-vitro studies intraorifice barrier has been suggested as an effective mean to provide seal against coronal microleakage. This study intends to clinically investigate efficacy of intraorifice barrier in healing of apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Intraorifice barrier of GIC, Base of GIC and Direct composite restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2016to 31 Jan 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mature permanent mandibular molars.
- 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 (size not more than 2 × 2mm);
Who cannot join
- Younger than 18 years;
- Pregnant, diabetic, or immunocompromised;
- Having a positive history of antibiotic use within the past month or require antibiotic premedication for dent treatment (including infective endocarditis or prosthetic joint prophylaxis);
- Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and his of recent periodontal therapy (within previous 6 months);
About this study
Official title: Effect of Intraorifice Barrier on Healing of Apical Periodontitis: A Randomized Clinical Study
Based on various in-vitro studies intraorifice barrier has been suggested as an effective mean to provide seal against coronal microleakage. This study intends to clinically investigate efficacy of intraorifice barrier in healing of apical periodontitis.
Read the detailed description
INTRODUCTION
Coronal leakage is considered significant factor for failure of endodontic treatment. In an array of retrospective studies significant number of cases were reported of apical periodontitis in teeth with unsatisfactory coronal seal as compared to the ones with clinically/radiographically acceptable coronal restoration. Gutta-percha and sealer alone used routinely as root canal obturating material is found to be ineffective to guard against microleakage. Even clinically acceptable root filling allow penetration of bacteria and their products in as less as three days and contribute to eventual treatment failure. This breach of seal in coronal segment of obturated root canal may significantly jeopardize endodontic treatment outcome.
Roghanizad suggested placement of intraorifice barrier to augment coronal seal in endodontically treated teeth. In his study teeth with intraorifice barriers leaked significantly less than the control group where no such barrier was placed. Since then numerous studies have established supremacy of intraorifice barrier and sealing of floor of pulp chamber in preventing coronal microleakage than the one without it. Various materials have been tested as intraorifice barrier. Some studies have reported no difference amongst materials.while other found better performance of MTA over composite and GIC ; GIC over Polycarboxylate cement and Flowable composite.and resilon also composite was found superior over MTA and Cavit and Cavit and IRM.
Various methodology has been employed to study coronal microleakage viz dye penetration ; bacterial penetration ; fluid filtration and glucose molecule penetration.
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. Importance of base has also been stressed by Hommez et al who in retrospective study found higher incidence of apical periodontitis in cases where base was absent even though endodontic treatment was adequate.
MATERIALS AND METHODOLOGY:
This study is conducted in the department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Study subjects were obtained from the pool of OPD patients in the Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak.
Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient. Prior informed consent was taken after explaining the procedure, risk and benefits.
Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) were chosen for the study.
All periapical radiographs were exposed by using constant kVP, mA and exposure time (70 KVP, 8 mA, 0.8 sec.) After initial periodontal therapy, administration of local anesthesia, rubber dam isolation of the involved tooth was done.
Caries excavation was done and access cavity was prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices were identified. Negotiation of canals was done. Working length was determined using root ZX apex locator and were verified radiographically.
After creating glide path with #15 k-file, Revo-S (Micro Mega, Besancon, France) instruments were used in sequence suggested by manufacturer with a rotational speed of 350 rpm in gentle in-out motion. The torque was adjusted to 2.5 Ncm, and a crown-down approach was selected. Once, the instrument had negotiated to the end of the canal and had rotated freely, it was removed.
Irrigation was carried out using 5 mL of a 5.25% NaOCl solution between files. After preparation, the root canals were irrigated with 5 mL 17% EDTA for 3 minutes to remove smear layer, followed by 5 mL 5.25% NaOCl. The final irrigation was done with 5 mL distilled water.
The root canals were dried using paper points and filled with laterally condensed gutta-percha (Meta Biomed Co Ltd, Korea) and Roth R-801 sealer (Roth International Drug Co., Chicago, Ill) mixed according to manufacturers' instruction
Gutta-percha was cut with a heated instrument and vertically condensed right at the orifice opening of the canals. The teeth were randomly divided into 3 experimental groups as follows :
- Group I: intraorifice barrier of glass-ionomer cement (KetacTM Molar, 3M ESPE) placed 3mm in the canal from root canal orifice.
- Group II: base of 2mm of glass-ionomer cement (KetacTM Molar, 3M ESPE) placed on the floor of the pulp chamber.
- Group III: control group with neither intraorifice barrier placed nor base applied.
In group I: The gutta-percha was removed 3mm from the coronal portion of the canal with hot plugger. Excess root canal sealer was removed with sterilized alcohol-wet cotton pellets. Glass Ionomer Cement was applied inside canal and condensed as well as 2mm thick uniform base on the floor of the pulp chamber.
In group II 2mm thick base of Glass Ionomer Cement was applied uniformly on the floor of the pulp chamber with plastic instrument.
Final composite restoration was placed in all groups according to the manufacturer's instructions. Periodontal therapy in the form of scaling and root planning was done on the day endodontic treatment was completed.
Follow up clinical and radiographic examination was carried out at 3, 6, 9 \& 12 month period.
- Conditions
- Apical Periodontitis
- Being tested
- Intraorifice barrier of GIC, Base of GIC, Direct composite restoration
- 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.
Intraorifice barrier of GICProcedure 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.
Base of GICProcedure 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.
Direct composite restorationProcedure 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.
| Study group | Role | What they receive |
|---|---|---|
| Intraorifice Group | Experimental | Intraorifice barrier of GIC. Receives: Procedure: Intraorifice barrier of GIC |
| Base Group | Experimental | Base of GIC Receives: Procedure: Base of GIC |
| Control Group | Active comparator | Direct composite restoration Receives: Procedure: Direct composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Success was defined as absence of signs and symptoms
Measured: Baseline to one year
Secondary outcomes (1)
Radiographic Success
Absence of periapical alterations (radiolucency at furcal or periapical region).
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 posted24 Jan 2018
- Study start14 Oct 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 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
- 75 participants (estimated)
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
- NCT03409887
- Sponsor's protocol ID
- Gaurav Kumar
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 23 May 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 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraorifice Barrier on Healing of Apical Periodontitis: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03409887
- Acronym / sponsor ID
- Gaurav Kumar
- Conditions
- Apical Periodontitis
- Keywords
- root canal treatment, intraorifice barrier.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 24 Jan 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.
Based on various in-vitro studies intraorifice barrier has been suggested as an effective mean to provide seal against coronal microleakage. This study intends to clinically investigate efficacy of intraorifice barrier in healing of apical periodontitis.
Detailed description
INTRODUCTION
Coronal leakage is considered significant factor for failure of endodontic treatment. In an array of retrospective studies significant number of cases were reported of apical periodontitis in teeth with unsatisfactory coronal seal as compared to the ones with clinically/radiographically acceptable coronal restoration. Gutta-percha and sealer alone used routinely as root canal obturating material is found to be ineffective to guard against microleakage. Even clinically acceptable root filling allow penetration of bacteria and their products in as less as three days and contribute to eventual treatment failure. This breach of seal in coronal segment of obturated root canal may significantly jeopardize endodontic treatment outcome.
Roghanizad suggested placement of intraorifice barrier to augment coronal seal in endodontically treated teeth. In his study teeth with intraorifice barriers leaked significantly less than the control group where no such barrier was placed. Since then numerous studies have established supremacy of intraorifice barrier and sealing of floor of pulp chamber in preventing coronal microleakage than the one without it. Various materials have been tested as intraorifice barrier. Some studies have reported no difference amongst materials.while other found better performance of MTA over composite and GIC ; GIC over Polycarboxylate cement and Flowable composite.and resilon also composite was found superior over MTA and Cavit and Cavit and IRM.
Various methodology has been employed to study coronal microleakage viz dye penetration ; bacterial penetration ; fluid filtration and glucose molecule penetration.
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. Importance of base has also been stressed by Hommez et al who in retrospective study found higher incidence of apical periodontitis in cases where base was absent even though endodontic treatment was adequate.
MATERIALS AND METHODOLOGY:
This study is conducted in the department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Study subjects were obtained from the pool of OPD patients in the Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak.
Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient. Prior informed consent was taken after explaining the procedure, risk and benefits.
Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) were chosen for the study.
All periapical radiographs were exposed by using constant kVP, mA and exposure time (70 KVP, 8 mA, 0.8 sec.) After initial periodontal therapy, administration of local anesthesia, rubber dam isolation of the involved tooth was done.
Caries excavation was done and access cavity was prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices were identified. Negotiation of canals was done. Working length was determined using root ZX apex locator and were verified radiographically.
After creating glide path with #15 k-file, Revo-S (Micro Mega, Besancon, France) instruments were used in sequence suggested by manufacturer with a rotational speed of 350 rpm in gentle in-out motion. The torque was adjusted to 2.5 Ncm, and a crown-down approach was selected. Once, the instrument had negotiated to the end of the canal and had rotated freely, it was removed.
Irrigation was carried out using 5 mL of a 5.25% NaOCl solution between files. After preparation, the root canals were irrigated with 5 mL 17% EDTA for 3 minutes to remove smear layer, followed by 5 mL 5.25% NaOCl. The final irrigation was done with 5 mL distilled water.
The root canals were dried using paper points and filled with laterally condensed gutta-percha (Meta Biomed Co Ltd, Korea) and Roth R-801 sealer (Roth International Drug Co., Chicago, Ill) mixed according to manufacturers' instruction
Gutta-percha was cut with a heated instrument and vertically condensed right at the orifice opening of the canals. The teeth were randomly divided into 3 experimental groups as follows :
- Group I: intraorifice barrier of glass-ionomer cement (KetacTM Molar, 3M ESPE) placed 3mm in the canal from root canal orifice.
- Group II: base of 2mm of glass-ionomer cement (KetacTM Molar, 3M ESPE) placed on the floor of the pulp chamber.
- Group III: control group with neither intraorifice barrier placed nor base applied.
In group I: The gutta-percha was removed 3mm from the coronal portion of the canal with hot plugger. Excess root canal sealer was removed with sterilized alcohol-wet cotton pellets. Glass Ionomer Cement was applied inside canal and condensed as well as 2mm thick uniform base on the floor of the pulp chamber.
In group II 2mm thick base of Glass Ionomer Cement was applied uniformly on the floor of the pulp chamber with plastic instrument.
Final composite restoration was placed in all groups according to the manufacturer's instructions. Periodontal therapy in the form of scaling and root planning was done on the day endodontic treatment was completed.
Follow up clinical and radiographic examination was carried out at 3, 6, 9 \& 12 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraorifice Group | Experimental | Procedure: Intraorifice barrier of GICIntraorifice barrier of GIC. |
| Base Group | Experimental | Procedure: Base of GICBase of GIC |
| Control Group | Active comparator | Procedure: Direct composite restorationDirect composite restoration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mature permanent mandibular molars.
- 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 (size not more than 2 × 2mm);
Key exclusion criteria (4 listed)
- Younger than 18 years;
- Pregnant, diabetic, or immunocompromised;
- Having a positive history of antibiotic use within the past month or require antibiotic premedication for dent treatment (including infective endocarditis or prosthetic joint prophylaxis);
- Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and his of recent periodontal therapy (within previous 6 months);
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 |
|---|---|---|
| Intraorifice barrier of GICAfter 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. | Procedure or surgery | Intraorifice Group |
| Base of GICAfter 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. | Procedure or surgery | Base Group |
| Direct composite restorationAfter 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. | Procedure or surgery | Control Group |
Primary outcome
Clinical success
Time frame: Baseline to one year
Success was defined as absence of signs and symptoms
1 secondary outcome
Radiographic Success
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 23 May 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 Intraorifice barrier of GIC, Base of GIC and Direct composite restoration 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 4 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 23 May 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?
Clinical success (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 23 May 2018.