Irreversible PulpitisNCT04654845
Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.
A study testing Pulpotomy and Pulpectomy in people with Irreversible Pulpitis, run by Aula Dental Avanzada at 4 sites in Spain.
Trial summary
To evaluate in a comparative way the perception of the patient who comes with pain due to irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy (or control group) or pulpotomy (or experimental group). Prospective randomized and multicenter study. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpotomy and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSpain
- Study dates
- 16 Nov 2020to 30 Jul 2022
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient in American Society of Anesthesiologists I or II condition.
- Patient who comes to the emergency room with irreversible pulpitis in a single tooth.
- Patients of age >20 years.
- Positive response to the vitality test and bleeding after pulp exposure.
Who cannot join
- American Society of Anesthesiologists patients>II.
- Pharmacological allergies that contraindicate the intervention.
- Teeth with negative vitality test and no bleeding after pulp exposure.
- Signs of concomitant periodontal infection such as swelling or fistula.
- Teeth with immature roots.
- Patients who are medicated with anxiolytics.
Show all 11Show fewer
- Abuse of psychotropic drugs or medication that may alter the perception of pain 15 days before the intervention.
- Pregnant or breast-feeding women.
- Interventions with conscious sedation.
- Pathological mental state (dementia, psychosis).
- Lack of collaboration or non-acceptance of the consent of the study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Clínica Dental esteve
Alicante, 03001
Clínica Dental Corbalán
Ceutí, Murcia, 30562
Centro Dental Navarro Ferri
Cullera, Valencia, 46400
Clínica Dental 4
Ferrol, A Coruña, 15402
About this study
Official title: Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis. A Randomized Multicenter Clinical Trial.
To evaluate in a comparative way the perception of the patient who comes with pain due to irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy (or control group) or pulpotomy (or experimental group).
Prospective randomized and multicenter study. It will be carried out in 4 centers of similar socio-professional characteristics, with the same operative protocol. On a significant sample of emergency patients with a concrete clinical manifestation of symptomatic irreversible pulpitis, one type of intervention or another will be performed randomly. The data will be collected by means of a visual numeric scale (NRS).
Read more
The null hypothesis is that both interventions provide the same reduction of pain in patients who present symptomatic irreversible pulpitis.
All the patients who come to one of the private centers with irreversible pulpitis and who meet the defined criteria for inclusion and exclusion will be selected.
The type of procedure that will be performed in the control group will be the complete removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy. The procedure to be performed in the experimental group will be the removal of the pulp only at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the "List Randomizer" (random.org) will be used for the randomization.
Read the detailed description
Clinical procedure will be the same in both groups with regard to the anesthetic technique, and the cavity access and provisional closure of the aperture. The characteristics of both interventions will be described in detail in order to homogenize the procedures. The patient will be conveniently informed before requesting his/her Informed Consent for his/her voluntary participation in the study. Their identification data will be treated in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in custody at the Center where they receive treatment and will not be shared by the other centers of the study.
The patient will not be aware of the type of procedure he has been assigned for and will express in a numerical scale according to his perception of the pain on 4 occasions: before starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving the treatment, he will answer some questions related to the degree of comfort during the treatment and about his perception of the time of the intervention.
Data sheets will be collected and treated statistically.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy, Pulpectomy
- Keywords
- Pulpotomy, Pulpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Wait until confirmation of absence of bleeding from the conducts. Placement of polytetrafluroethylene in pulp chamber. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.
PulpectomyProcedure or surgery
Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
Establishment of working length by means of Electronic Apex Locator and a number 8 K file.
Access to all conducts with a number 10 K file. Rotary instrumentation with one reciprocating system up to working length and up to an apical diameter of 25.
Placement of polytetrafluroethylene in pulp chamber. No intermediate medication will be filled into the conducts.
Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Only the tissue in the pulp chamber will be removed. Receives: Procedure: Pulpotomy |
| Pulpectomy | Active comparator | Both the chamber´s and root´s pulp tissue will be removed up to a 25 gauge. Receives: Procedure: Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients´ pain perception
The patient's perception of the degree of post-operative pain following emergency treatment
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Procedure time
The time it takes for each procedure.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start16 Nov 2020
- Primary completion29 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- 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
- Model description
- Participants with irreversible pulpitis are randomly assigned to one type of intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, DDS, Principal investigator, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654845
- Sponsor's protocol ID
- PULP
- Status last verified
- Aug 2022
- First submitted
- 27 Nov 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gatewood RS, Himel VT, Dorn SO. Treatment of the endodontic emergency: a decade later. J Endod. 1990 Jun;16(6):284-91. doi: 10.1016/S0099-2399(06)81631-6.
PubMed 2074427Lee M, Winkler J, Hartwell G, Stewart J, Caine R. Current trends in endodontic practice: emergency treatments and technological armamentarium. J Endod. 2009 Jan;35(1):35-9. doi: 10.1016/j.joen.2008.10.007.
PubMed 19084121Nyerere JW, Matee MI, Simon EN. Emergency pulpotomy in relieving acute dental pain among Tanzanian patients. BMC Oral Health. 2006 Jan 21;6:1. doi: 10.1186/1472-6831-6-1.
PubMed 16426455Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
PubMed 21419285Eghbal MJ, Haeri A, Shahravan A, Kazemi A, Moazami F, Mozayeni MA, Saberi E, Samiei M, Vatanpour M, Akbarzade Baghban A, Fazlyab M, Parhizkar A, Ahmadi M, Akbarian Rad N, Bijari S, Bineshmarvasti D, Davoudi P, Dehghan R, Dehghani M, Ebrahimi H, Emami N, Farajian N, Fereidooni R, Ghobadi G, Ghodrati M, Gohari A, Hashemi A, Hosseini M, Karami E, Kheirabadi N, Kozegari S, Labaf Ghasemi H, Majidi A, Malekzadeh P, Mehrabi V, Mohammadi M, Moradi Eslami L, Noghani A, Omatali N, Pourhatami N, Rahbani Nobar B, Rahmani S, Shafaq P, Soofiabadi S, Teimoori S, Vatandoost F, Asgary S. Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial. Pain Res Manag. 2020 Jun 30;2020:5853412. doi: 10.1155/2020/5853412. eCollection 2020.
PubMed 32676136Eren B, Onay EO, Ungor M. Assessment of alternative emergency treatments for symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J. 2018 Apr;51 Suppl 3:e227-e237. doi: 10.1111/iej.12851. Epub 2017 Oct 16.
PubMed 28857203Oguntebi BR, DeSchepper EJ, Taylor TS, White CL, Pink FE. Postoperative pain incidence related to the type of emergency treatment of symptomatic pulpitis. Oral Surg Oral Med Oral Pathol. 1992 Apr;73(4):479-83. doi: 10.1016/0030-4220(92)90330-s.
PubMed 1574311
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis. A Randomized Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT04654845
- Acronym / sponsor ID
- PULP
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpotomy, Pulpectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 4 Dec 2020 (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.
To evaluate in a comparative way the perception of the patient who comes with pain due to irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy (or control group) or pulpotomy (or experimental group).
Prospective randomized and multicenter study. It will be carried out in 4 centers of similar socio-professional characteristics, with the same operative protocol. On a significant sample of emergency patients with a concrete clinical manifestation of symptomatic irreversible pulpitis, one type of intervention or another will be performed randomly. The data will be collected by means of a visual numeric scale (NRS).
The null hypothesis is that both interventions provide the same reduction of pain in patients who present symptomatic irreversible pulpitis.
All the patients who come to one of the private centers with irreversible pulpitis and who meet the defined criteria for inclusion and exclusion will be selected.
The type of procedure that will be performed in the control group will be the complete removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy. The procedure to be performed in the experimental group will be the removal of the pulp only at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the "List Randomizer" (random.org) will be used for the randomization.
Detailed description
Clinical procedure will be the same in both groups with regard to the anesthetic technique, and the cavity access and provisional closure of the aperture. The characteristics of both interventions will be described in detail in order to homogenize the procedures. The patient will be conveniently informed before requesting his/her Informed Consent for his/her voluntary participation in the study. Their identification data will be treated in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in custody at the Center where they receive treatment and will not be shared by the other centers of the study.
The patient will not be aware of the type of procedure he has been assigned for and will express in a numerical scale according to his perception of the pain on 4 occasions: before starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving the treatment, he will answer some questions related to the degree of comfort during the treatment and about his perception of the time of the intervention.
Data sheets will be collected and treated statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants with irreversible pulpitis are randomly assigned to one type of intervention.
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyOnly the tissue in the pulp chamber will be removed. |
| Pulpectomy | Active comparator | Procedure: PulpectomyBoth the chamber´s and root´s pulp tissue will be removed up to a 25 gauge. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient in American Society of Anesthesiologists I or II condition.
- Patient who comes to the emergency room with irreversible pulpitis in a single tooth.
- Patients of age >20 years.
- Positive response to the vitality test and bleeding after pulp exposure.
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists patients>II.
- Pharmacological allergies that contraindicate the intervention.
- Teeth with negative vitality test and no bleeding after pulp exposure.
- Signs of concomitant periodontal infection such as swelling or fistula.
- Teeth with immature roots.
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 |
|---|---|---|
| PulpotomyAccess to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator. Wait until confirmation of absence of bleeding from the conducts. Placement of polytetrafluroethylene in pulp chamber. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ. | Procedure or surgery | Pulpotomy |
| PulpectomyAccess to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator. Establishment of working length by means of Electronic Apex Locator and a number 8 K file. Access to all conducts with a number 10 K file. Rotary instrumentation with one reciprocating system up to working length and up to an apical diameter of 25. Placement of polytetrafluroethylene in pulp chamber. No intermediate medication will be filled into the conducts. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ. | Procedure or surgery | Pulpectomy |
Primary outcome
Patients´ pain perception
Time frame: Through study completion, an average of 1 year.
The patient's perception of the degree of post-operative pain following emergency treatment
1 secondary outcome
Procedure time
Time frame: Through study completion, an average of 1 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 11 Aug 2022.
- Background: PubMed 2074427Gatewood RS, Himel VT, Dorn SO. Treatment of the endodontic emergency: a decade later. J Endod. 1990 Jun;16(6):284-91. doi: 10.1016/S0099-2399(06)81631-6.
- Background: PubMed 19084121Lee M, Winkler J, Hartwell G, Stewart J, Caine R. Current trends in endodontic practice: emergency treatments and technological armamentarium. J Endod. 2009 Jan;35(1):35-9. doi: 10.1016/j.joen.2008.10.007.
- Background: PubMed 16426455Nyerere JW, Matee MI, Simon EN. Emergency pulpotomy in relieving acute dental pain among Tanzanian patients. BMC Oral Health. 2006 Jan 21;6:1. doi: 10.1186/1472-6831-6-1.
- Background: PubMed 21419285Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
- Results publication: PubMed 32676136Eghbal MJ, Haeri A, Shahravan A, Kazemi A, Moazami F, Mozayeni MA, Saberi E, Samiei M, Vatanpour M, Akbarzade Baghban A, Fazlyab M, Parhizkar A, Ahmadi M, Akbarian Rad N, Bijari S, Bineshmarvasti D, Davoudi P, Dehghan R, Dehghani M, Ebrahimi H, Emami N, Farajian N, Fereidooni R, Ghobadi G, Ghodrati M, Gohari A, Hashemi A, Hosseini M, Karami E, Kheirabadi N, Kozegari S, Labaf Ghasemi H, Majidi A, Malekzadeh P, Mehrabi V, Mohammadi M, Moradi Eslami L, Noghani A, Omatali N, Pourhatami N, Rahbani Nobar B, Rahmani S, Shafaq P, Soofiabadi S, Teimoori S, Vatandoost F, Asgary S. Postendodontic Pain after Pulpotomy or Root Canal Treatment in Mature Teeth with Carious Pulp Exposure: A Multicenter Randomized Controlled Trial. Pain Res Manag. 2020 Jun 30;2020:5853412. doi: 10.1155/2020/5853412. eCollection 2020.
- Results publication: PubMed 28857203Eren B, Onay EO, Ungor M. Assessment of alternative emergency treatments for symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J. 2018 Apr;51 Suppl 3:e227-e237. doi: 10.1111/iej.12851. Epub 2017 Oct 16.
- Results publication: PubMed 1574311Oguntebi BR, DeSchepper EJ, Taylor TS, White CL, Pink FE. Postoperative pain incidence related to the type of emergency treatment of symptomatic pulpitis. Oral Surg Oral Med Oral Pathol. 1992 Apr;73(4):479-83. doi: 10.1016/0030-4220(92)90330-s.
- Individual participant dataSharing planned: No
Related trials for Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
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.
Guillem Esteve-Pardo, DDS principal investigator
Aula Dental Avanzada
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Pulpectomy in people with Irreversible Pulpitis, run by Aula Dental Avanzada at 4 sites in Spain.
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 4 inclusion and 11 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Patients´ pain perception (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654845, which also lists 7 linked publications.
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 11 Aug 2022.