Assessment of the procedure duration and success of alternative emergency treatments for patients with painful dental pulp disease
| ISRCTN | ISRCTN14290358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14290358 |
| Secondary identifying numbers | D-KA16/08 |
- Submission date
- 07/06/2017
- Registration date
- 08/06/2017
- Last edited
- 15/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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)
Contact information
Scientific
Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26, Bahcelievler
Ankara
06490
Türkiye
 ORCID ID |
0000-0001-5800-8871 |
|---|---|
| Phone | +90 312 203 0000 |
| eonay@baskent.edu.tr |
Scientific
Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26
Bahcelievler
Ankara
06490
Türkiye
| Phone | +90 312 203 0000 |
|---|---|
| birguleren85@hotmail.com |
Scientific
Department of Endodontics
Faculty of Dentistry
Baskent University
82. sok. No. 26
Bahcelievler
Ankara
06490
Türkiye
Study information
| Study design | Single-blinded single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Baskent University Institutional Review Board and Ethics Committee, 15/04/2016, ref: D-KA16/08. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/02/2016 |
| Completion date | 04/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 66 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 20/04/2016 |
| Date of final enrolment | 25/01/2017 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Bahcelievler
Ankara
06490
Türkiye
Sponsor information
University/education
Taskent Caddesi 77
Sokak No: 11
Bahcelievler
Cankaya
Ankara
06490
Türkiye
| Phone | +90 312 212 9065 |
|---|---|
| arastirma@baskent.edu.tr | |
| Website | http://tip.baskent.edu.tr/kw/genel.php?birim=600&id=2486&menu_id=19 |
"ROR" |
https://ror.org/02v9bqx10 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Baskent University
- Location
- Türkiye
Results and Publications
| Intention to publish date | 15/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | Yes | No |
Editorial Notes
15/03/2018: Publication reference added.
