CompletedNot Applicable

Effect of Coronal Extent of Obturation on Endo-perio Lesions

60 participantsStarted 2016-10-14

Plain-language summary

Increased incidence of apical periodontitis was reported where root filling was found coronal to the marginal bone due to communication between pulp and periodontal space. It has been suggested to place intraorifice barrier in the canal to provide coronal seal. However there exists a void in literature regarding clinical validity of the termination of obturation apical to marginal bone and placement of intraorifice barrier in resolution of periapical pathology. Therefore this randomized controlled trial intends to investigate effect of coronal level of obturation on endodontic success and marginal breakdown.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 × 2 mm);
. Generalized chronic periodontitis criteria will be considered when ≥ 30% of sites will be involved with clinical attachment loss (CAL) slight = 1or 2mm, Moderate = 3-4mm, and severe ≥ 5mm.
. Probing depth\<4mm
. Radiographic alveolar bone breakdown not more than one third of root length.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical success

Timeframe: Baseline to one year.

Radiographic Success

Timeframe: Baseline to one year

Trial details

NCT IDNCT03171376

SponsorPostgraduate Institute of Dental Sciences Rohtak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-15

View on ClinicalTrials.gov More Apical Periodontitis trials