Condition category
Oral Health
Date applied
07/06/2017
Date assigned
08/06/2017
Last edited
12/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The dental pulp which is the soft tissue inside the root canal, can become inflamed (swollen) due to a variety reasons, such as deep decay, traumatic injuries, gum disease and repeated dental procedures on the tooth. If pulp inflammation is left untreated, it can cause pain. Ideally, emergency treatment for painful pulp disease involves removing all of the inflamed or infected pulp from the root canals (total pulpectomy), cleaning the inside of the root canal, then filling and sealing the space temporarily. However, root canal emergencies due to painful pulp disease require unscheduled office visits, cause inconvenience, and disrupt routine schedules. In such cases, the time required to intervene is often an issue. Moreover, emergency root canal procedures, like other dental treatments, may be interrupted by unexpected and unfavourable “procedural errors" due to time constraints. Many such problems can be avoided by applying acceptable, simplified treatment technique that will relieve pain quickly and efficiently in cases of painful pulp disease. Accordingly, the removal of a portion of the pulp within the tooth crown only (pulpotomy) or removal of the pulp tissue from the crown and the largest root canal (partial pulpectomy) has been recommended for emergency treatment of painful pulp disease (symptomatic irreversible pulpitis). The aim of this study therefore is to find out whether performing pulpotomy or partial pulpectomy can relieve pain effectively and reduce the procedure duration.

Who can participate?
Adults with dental pain who have been diagnosed with painful pulp disease.

What does the study involve?
Participants are asked to join this study while they are at the emergency dental service. Participants are randomly allocated to one of three groups. Those in the first group receive total pulpectomy, which involves removing all of the pulp tissue. Those in the second group receive partial pulpectomy, which involves removing some of the pulp tissue. Those in the third group receive pulpotomy, which involves removing specific pulp tissue. Participants are asked to record pain intensity using a scale that ranged from no pain to unbearable pain and history of pain upon chewing and thermal (hot and cold) at the beginning of the study. Once a procedure is finished, the patient is prescribed pain killers. Participants are asked to complete questionnaires about daily pain relief requirements and about clinical symptoms (pain intensity, chewing sensitivity, and hot and cold sensitivity) after the anaesthetic (numbing injection) has worn off and then one, three and seven days following treatment. All participants are scheduled for root canal treatment completion at appropriate intervals after the research period.

What are the possible benefits and risks of participating?
Participants benefit from having the costs of their treatments covered. There are no notable risks involved with participating.

Where is the study run from?
Baskent University Faculty of Dentistry (Turkey)

When is study starting and how long is it expected to run for?
February 2016 to April 2017

Who is funding the study?
Baskent University Research Fund

Who is the main contact?
1. Dr Emel Olga Onay (scientific)
eonay@baskent.edu.tr
2. Dr Birgul Eren (scientific)
birguleren85@hotmail.com
3. Professor Mete Ungor (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emel Olga Onay

ORCID ID

http://orcid.org/0000-0001-5800-8871

Contact details

Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26
Bahcelievler
Ankara
06490
Turkey
+90 312 203 0000
eonay@baskent.edu.tr

Type

Scientific

Additional contact

Dr Birgul Eren

ORCID ID

Contact details

Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26
Bahcelievler
Ankara
06490
Turkey
+90 312 203 0000
birguleren85@hotmail.com

Type

Scientific

Additional contact

Prof Mete Ungor

ORCID ID

Contact details

Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26
Bahcelievler
Ankara
06490
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D-KA16/08

Study information

Scientific title

Assessment of the procedure duration and efficacy of pulpotomy and partial pulpectomy in comparison with total pulpectomy for patients with symptomatic irreversible pulpitis: a randomized clinical trial

Acronym

Study hypothesis

Performing pulpotomy or partial pulpectomy aimed at relieving pain effectively and reducing the procedure duration in emergency cases with symptomatic irreversible pulpitis. This in turn will maintain the clinicians' ability to intervene in the clinical setting of a busy practice with limited time for emergencies.

Ethics approval

Baskent University Institutional Review Board and Ethics Committee, 15/04/2016, ref: D-KA16/08.

Study design

Single-blinded single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Symptomatic irreversible pulpitis

Intervention

Participants are randomised to one of three groups using sealed envelope randomisation.

Intervention group 1: Participants undergo pulpotomy treatment during a single-visit. This involves removing the coronal pulp tissue with a sterile curette, which followed by achieving haemostasis using dry cotton pellets and applying light pressure, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per pulpotomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Intervention group 2: Participants undergo partial pulpectomy treatment during a single-visit. This involves removing the pulp tissue from the pulp chamber and the largest canal (i.e. the palatal canals of maxillary molars and distal canals of mandibular molars) with sterile curettes and barbed broaches, which followed by working length determination, cleaning and initial shaping procedures, dressing, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per partial pulpectomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Control group: Participants undergo conventional total pulpectomy treatment during a single-visit. This involves removing the entire pulp tissue from the tooth with barbed broaches, which followed by working length determination, cleaning and initial shaping procedures, dressing, and placing a temporary filling after induction of an adequate anaesthesia and completion of the cavity preparation. The total time per total pulpectomy treatment is recorded for each tooth, with timing initiated once access cavity preparation is complete.

Follow up takes place once the anaesthetic effect has disappeared (Day 0), and subsequently on days 1, 3, and 7 post-procedure and involves recording three pain measures: postoperative pain intensity (visual analogue score), pain upon chewing (absent/present), and pain upon thermal stimulus (absent/present) on the questionnaires by the patients. Additional follow up takes place from the time the anaesthetic effect wore off to the end of that day (Day 0), and on each subsequent day of the first postoperative week and involves recording the frequencies and amounts of analgesic use on the questionnaires by the patients.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Pain intensity is measured using a visual analogue scale (VAS) at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
2. Pain relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in pain intensity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)
3. Total time per procedure per tooth is expressed in minutes during surgery

Secondary outcome measures

1. Daily analgesic requirements from the time the anaesthetic wore off (Day 0) throughout the 7 days post-surgery is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the frequencies and amounts of analgesic use per patient at Day 0, and 1, 2, 3, 4, 5, 6, and 7 days post-treatment
2. Proportion of patients with thermal sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
3. Thermal sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of thermal sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)
4. Proportion of patients with chewing sensitivity is measured by reviewing “Clinical Evaluation Questionnaire” forms and calculating the percentage at baseline, after the anaesthetic effect has disappeared (Day 0) and 1, 3, and 7 days post-treatment
5. Chewing sensitivity relief is assessed by reviewing “Clinical Evaluation Questionnaire” forms and calculating the changes in prevalence of chewing sensitivity between each reporting time points (baseline-Day 0; baseline- Day 1; baseline-Day 3; baseline-Day 7; Day 0-Day 1; Day 0-Day 3; Day 0-Day 7; Day 1-Day 3; Day 1-Day 7; Day 3-Day 7)

Overall trial start date

15/02/2016

Overall trial end date

04/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 60 years
2. Male or female
2. Acute dental pain in posterior maxillary or mandibular molar teeth
4. Diagnosed with symptomatic irreversible pulpitis with or without symptomatic apical periodontitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66

Participant exclusion criteria

1. History of American Society of Anesthesiologists (1963) III-VI status
2. Pregnancy or nursing
3. Mental disability
4. History of allergy to nonsteroidal anti-inflammatory drugs, and analgesic treatment during the 12 hours prior to presentation
5. If the subject tooth has moderate or severe marginal periodontitis, horizontal or vertical fractures, internal or external root resorption, root canal calcification, or a nonrestorable crown defect
6. If an opposing and/or neighbouring tooth has defective restorations, deep caries, moderate or severe marginal periodontitis, wear, or history of recent tooth preparation.

Recruitment start date

20/04/2016

Recruitment end date

25/01/2017

Locations

Countries of recruitment

Turkey

Trial participating centre

Baskent University, Faculty of Dentistry
82. sok. No. 26 Bahcelievler
Ankara
06490
Turkey

Sponsor information

Organisation

Baskent University

Sponsor details

Taskent Caddesi 77
Sokak No: 11
Bahcelievler
Cankaya
Ankara
06490
Turkey
+90 312 212 9065
arastirma@baskent.edu.tr

Sponsor type

University/education

Website

http://tip.baskent.edu.tr/kw/genel.php?birim=600&id=2486&menu_id=19

Funders

Funder type

University/education

Funder name

Baskent Üniversitesi

Alternative name(s)

Baskent University

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Turkey

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Emel Olga Onay (eonay@baskent.edu.tr) or Dr Birgul Eren (birguleren85@hotmail.com)

Intention to publish date

15/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes