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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

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 groups in NCT03711942
Study groupRoleWhat they receive
Periodontally Healthy IOBActive comparatorIntra orifice barrier (IOB) was placed in periodontally healthy molar.
Receives: Procedure: Intra orifice barrier
Periodontally Healthy BaseExperimental2mm thick base was applied in periodontally health teeth.
Receives: Procedure: Base
Periodontally healthy controlExperimentalcoronal access was restored with composite resin without any base.
Receives: Procedure: Control
Periodontally diseased IOBActive comparatorIntra orifice barrier (IOB) was placed in periodontally healthy molar
Receives: Procedure: Intra orifice barrier
Periodontally diseased BaseActive comparator2mm thick Base of GIC was applied under composite restoration
Receives: Procedure: Base
Periodontally diseased controlActive comparatorcoronal 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.

  1. 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)
  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.

  1. First posted19 Oct 2018
  2. Study start15 Oct 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

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)
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

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.

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