PulpitisPOPAVPTNCT06216951
Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis
An observational study of Pulpitis and Post Operative Pain, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Pulpitis, Post Operative Pain, Toothache
- What is being tested?
- Vital Pulpotomy
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Mar 2024
- Phase
- Observational
- 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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged between 7 and 70 with a noncontributory medical history presented for endodontic treatment at the Department of Endodontics and Department of Pediatric Dentistry, Faculty of Dentistry, Usak University, Turkey
Who may be able to join
- Patients aged between 7 and 70 years
- The teeth with diagnosis of irreversible symptomatic pulpitis
- Permanent first and second molars with vital pulp
- PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, \& Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)
Who cannot join
- Clinical or radiographic signs of a necrotic pulp
- The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph
- Teeth with horizontal or vertical root fractures
- Swelling, acute endodontic, or periodontal abscess
- Insufficient tooth tissue for a restoration, teeth requiring a post
- Unable to give informed consent
Show all 11Show fewer
- Contraindicated systemic disease
- Allergies the local anesthesia
- Antibiotics, biphosphonates, and corticosteroid intake during the 7 days before treatment.
- Pregnancy or breastfeeding.
- Patients who needed endodontic treatment on several teeth to avoid a potentially confused pain referral.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University School of Dentistry Department of Endodontics
Uşak, 64200
About this study
Official title: Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study
The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are:
- Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis?
- How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake?
Read more
Participants will:
- Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA)
- Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment.
If there is a comparison group:
Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.
Read the detailed description
Informed Consent:
Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time.
Sample Size Calculation:
Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108.
Treatment Procedure:
Vital pulpotomy, administered by experienced professionals, involved local anesthesia, rubber dam isolation, caries removal, pulp amputation, hemostasis, application of ProRoot MTA and glass ionomer, and permanent restoration. Pain scores, assessed using the modified Wong-Baker scale, were recorded pre-treatment, at 24 and 72 hours post-procedure, along with inquiries about painkiller usage.
- Conditions
- Pulpitis, Post Operative Pain, Toothache
- Being tested
- Vital Pulpotomy
- Keywords
- toothache, pulpitis, pulpotomy, pain, postoperative
- Medical subject headings
- Pulpitis, Pain, Postoperative, Toothache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital PulpotomyProcedure or surgery
Also called vital pulp amputation
Vital pulpotomy involves the removal of the coronal pulp, while MTA is used to seal the root orifices. It is clear that vital pulp treatments for symptomatic pulpitis are a more reliable, cost-effective, and generally easier option than root canal treatment (RCT) once the mineral trioxide aggregate (MTA) is introduced in dentistry. In vital pulpotomy, as opposed to RCT, tooth healing and symptoms are diminished while the vitality of the tooth is maintained. Furthermore, vital pulpotomy is a significantly more practical and economical treatment alternative than RCT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic pulpitis | vital permanent molars with symptomatic pulpitis in patients aged between 7-70 Receives: Procedure: Vital Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assesment
Pain scores before and after treatment will be assessed using a modified Wong-Baker pain rating scale. The patients and parents will be given with comprehensive information and instructed to indicate their level of pain using a pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain) before treatment, at 24 hours, and 72 hours after the procedure. Additionally, they will be asked about the use of painkillers.
Measured: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Dec 2021
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasibe Elif Kuru, Uşak University
- Investigators
- Berk Çelikkol, Dr, Principal investigator, Usak University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216951
- Sponsor's protocol ID
- 180-180-13
- Acronym
- POPAVPT
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to possible plagiarism issues, we are kindly requesting that the study descriptions be shared only after journal publication
Publications
Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21.
PubMed 31865629Zanini M, Hennequin M, Cousson PY. A Review of Criteria for the Evaluation of Pulpotomy Outcomes in Mature Permanent Teeth. J Endod. 2016 Aug;42(8):1167-74. doi: 10.1016/j.joen.2016.05.008. Epub 2016 Jun 20.
PubMed 27339631Witherspoon DE, Small JC, Harris GZ. Mineral trioxide aggregate pulpotomies: a case series outcomes assessment. J Am Dent Assoc. 2006 May;137(5):610-8. doi: 10.14219/jada.archive.2006.0256.
PubMed 16739540
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06216951
- Acronym / sponsor ID
- POPAVPT / 180-180-13
- Conditions
- Pulpitis, Post Operative Pain, Toothache
- Keywords
- toothache, pulpitis, pulpotomy, pain, postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 22 Jan 2024 (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.
The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are:
- Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis?
- How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake?
Participants will:
- Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA)
- Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment.
If there is a comparison group:
Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.
Detailed description
Informed Consent:
Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time.
Sample Size Calculation:
Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108.
Treatment Procedure:
Vital pulpotomy, administered by experienced professionals, involved local anesthesia, rubber dam isolation, caries removal, pulp amputation, hemostasis, application of ProRoot MTA and glass ionomer, and permanent restoration. Pain scores, assessed using the modified Wong-Baker scale, were recorded pre-treatment, at 24 and 72 hours post-procedure, along with inquiries about painkiller usage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic pulpitis | – | Procedure: Vital Pulpotomyvital permanent molars with symptomatic pulpitis in patients aged between 7-70 |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged between 7 and 70 with a noncontributory medical history presented for endodontic treatment at the Department of Endodontics and Department of Pediatric Dentistry, Faculty of Dentistry, Usak University, Turkey
Key inclusion criteria (4 listed)
- Patients aged between 7 and 70 years
- The teeth with diagnosis of irreversible symptomatic pulpitis
- Permanent first and second molars with vital pulp
- PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, \& Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)
Key exclusion criteria (11 listed)
- Clinical or radiographic signs of a necrotic pulp
- The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph
- Teeth with horizontal or vertical root fractures
- Swelling, acute endodontic, or periodontal abscess
- Insufficient tooth tissue for a restoration, teeth requiring a post
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 |
|---|---|---|
| Vital PulpotomyAlso: vital pulp amputationVital pulpotomy involves the removal of the coronal pulp, while MTA is used to seal the root orifices. It is clear that vital pulp treatments for symptomatic pulpitis are a more reliable, cost-effective, and generally easier option than root canal treatment (RCT) once the mineral trioxide aggregate (MTA) is introduced in dentistry. In vital pulpotomy, as opposed to RCT, tooth healing and symptoms are diminished while the vitality of the tooth is maintained. Furthermore, vital pulpotomy is a significantly more practical and economical treatment alternative than RCT. | Procedure or surgery | Patients with symptomatic pulpitis |
Primary outcome
Postoperative Pain Assesment
Time frame: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later
Pain scores before and after treatment will be assessed using a modified Wong-Baker pain rating scale. The patients and parents will be given with comprehensive information and instructed to indicate their level of pain using a pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain) before treatment, at 24 hours, and 72 hours after the procedure. Additionally, they will be asked about the use of painkillers.
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 27 Aug 2024.
- Background: PubMed 31865629Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21.
- Background: PubMed 27339631Zanini M, Hennequin M, Cousson PY. A Review of Criteria for the Evaluation of Pulpotomy Outcomes in Mature Permanent Teeth. J Endod. 2016 Aug;42(8):1167-74. doi: 10.1016/j.joen.2016.05.008. Epub 2016 Jun 20.
- Background: PubMed 16739540Witherspoon DE, Small JC, Harris GZ. Mineral trioxide aggregate pulpotomies: a case series outcomes assessment. J Am Dent Assoc. 2006 May;137(5):610-8. doi: 10.14219/jada.archive.2006.0256.
- Individual participant dataSharing planned: No. due to possible plagiarism issues, we are kindly requesting that the study descriptions be shared only after journal publication
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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.
Berk Çelikkol, Dr principal investigator
Usak University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulpitis and Post Operative Pain, run by Uşak University at 1 site in Turkey (Türkiye).
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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Postoperative Pain Assesment (time frame: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later). 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 NCT06216951, which also lists 3 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 27 Aug 2024.