Postoperative PainNCT04310254
Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth
A study testing EDTA and CHX Solution, EDTA Solution and CHX Solution in people with Postoperative Pain and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after root canal treatment using different final irrigation protocols. Patients whom need root canal treatment for first time were included. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Endodontically Treated Teeth
- What is being tested?
- EDTA and CHX Solution, EDTA Solution and CHX Solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Mar 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients who were healthy volunteers and who have devital premolar and molar teeth with PAI 3-5score requiring root canal treatment for first time.
- Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
Show all 9Show fewer
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde root canal treatment.
Who cannot join
- -The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Comparative Evaluation of Different Final Irrigation Protocols on Postoperative Endodontic Pain In Devital Teeth: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after root canal treatment using different final irrigation protocols. Patients whom need root canal treatment for first time were included. The presence of postoperative pain was assessed after root canal treatment cases at 12, 24, 48, 72 hrs and 1 week.
Read the detailed description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain following different final irrigation procedures. Patients who have asymptomaticdevital teeth required endodontic treatment were included in this study and routine root canal treatment procedure was applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Ninety asymptomatic teeth were randomly participated into 3 treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 12, 24, 48, 72 hrs and 1 week. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal treatment procedure was applied. Different final irrigation solutions applied in accordance to the manufacturers' instructions. At the end of treatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.
- Conditions
- Postoperative Pain, Endodontically Treated Teeth
- Being tested
- EDTA and CHX Solution, EDTA Solution, CHX Solution
- Keywords
- Endodontics, Postoperative Pain, Visual Analogue Pain Scale
- Medical subject headings
- Pain, Postoperative, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTA and CHX SolutionProcedure or surgery
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with Qmix 2in1 solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
EDTA SolutionProcedure or surgery
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with EDTA solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
CHX SolutionProcedure or surgery
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with CHX solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
| Study group | Role | What they receive |
|---|---|---|
| EDTA and CHX solution | Active comparator | Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA and CHX solution. Receives: Procedure: EDTA and CHX Solution |
| EDTA solution | Active comparator | Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA solution. Receives: Procedure: EDTA Solution |
| CHX solution | Active comparator | Root canal irrigation was performed according to the guidelines to the manufacturers instructions for CHX solution. Receives: Procedure: CHX Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root canal treatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Measured: Baseline, 12, 24, 48, 72 hours and 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Sep 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Parallel Assignment The patients were assigned to 3 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keziban Olcay, DDS, Phd, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310254
- Sponsor's protocol ID
- 929
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Comparative Evaluation of Different Final Irrigation Protocols on Postoperative Endodontic Pain In Devital Teeth: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04310254
- Acronym / sponsor ID
- 929
- Conditions
- Postoperative Pain, Endodontically Treated Teeth
- Keywords
- Endodontics, Postoperative Pain, Visual Analogue Pain Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Mar 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.
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after root canal treatment using different final irrigation protocols. Patients whom need root canal treatment for first time were included. The presence of postoperative pain was assessed after root canal treatment cases at 12, 24, 48, 72 hrs and 1 week.
Detailed description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain following different final irrigation procedures. Patients who have asymptomaticdevital teeth required endodontic treatment were included in this study and routine root canal treatment procedure was applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Ninety asymptomatic teeth were randomly participated into 3 treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 12, 24, 48, 72 hrs and 1 week. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal treatment procedure was applied. Different final irrigation solutions applied in accordance to the manufacturers' instructions. At the end of treatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment The patients were assigned to 3 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
| Arm | Type | Receives |
|---|---|---|
| EDTA and CHX solution | Active comparator | Procedure: EDTA and CHX SolutionRoot canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA and CHX solution. |
| EDTA solution | Active comparator | Procedure: EDTA SolutionRoot canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA solution. |
| CHX solution | Active comparator | Procedure: CHX SolutionRoot canal irrigation was performed according to the guidelines to the manufacturers instructions for CHX solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -Patients who were healthy volunteers and who have devital premolar and molar teeth with PAI 3-5score requiring root canal treatment for first time.
- Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
Key exclusion criteria (1 listed)
- -The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
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 |
|---|---|---|
| EDTA and CHX SolutionThe teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with Qmix 2in1 solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary. | Procedure or surgery | EDTA and CHX solution |
| EDTA SolutionThe teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with EDTA solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary. | Procedure or surgery | EDTA solution |
| CHX SolutionThe teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with CHX solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary. | Procedure or surgery | CHX solution |
Primary outcome
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week.
Time frame: Baseline, 12, 24, 48, 72 hours and 1 week.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root canal treatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
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 7 Apr 2020.
Related trials for Postoperative Pain
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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.
Keziban Olcay, DDS, Phd principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDTA and CHX Solution, EDTA Solution and CHX Solution in people with Postoperative Pain and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital 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 9 inclusion and 1 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 7 Apr 2020. 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?
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week. (time frame: Baseline, 12, 24, 48, 72 hours and 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.