Pain, PostoperativeNCT04944589
Comparison of Post-operative Pain Frequency
A study testing ROOT CANAL TREATMENT in people with Pain, Postoperative, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
The objective of this study is: To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ROOT CANAL TREATMENT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2019to 28 Feb 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients within age range 20-40 years.
- Male/Female
- Mature permanent first and second molar teeth (maxillary and mandibular)
- Non-vital teeth (As defined in operational definitions)
Who cannot join
- • Any contraindication to local anesthesia, e.g. known allergy
- Pregnancy.
- endodontic re-treatment cases
- Any physical or mental condition that would prevent jaw opening for the time required to complete the treatment.
- Local acute infection/periapical radiolucency (diagnosed clinically, radio graphically )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post-operative Pain Frequency in Non-vital Teeth After Single Visit Root Canal Versus Multiple Visit Root Canal Treatment
The objective of this study is:
- To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
- Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.
Read the detailed description
METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits.
The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on Visual Analogue Scale (VAS) scale was considered as absence of pain.
The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.
- Conditions
- Pain, Postoperative
- Being tested
- ROOT CANAL TREATMENT
- Keywords
- Endodontics, Non-vital teeth, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROOT CANAL TREATMENTProcedure or surgery
Clinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics.
| Study group | Role | What they receive |
|---|---|---|
| single visit root canal treatment(RCT) | Experimental | RCT(ROOT CANAL TREATMENT) of this group was performed in single visit including access cavity, chemo-mechanical preparation and obturation, all were done in one visit Receives: Procedure: ROOT CANAL TREATMENT |
| Multiple visit root canal treatment(RCT) | Experimental | RCT(ROOT CANAL TREATMENT) of this group was performed in multiple visit including access cavity, chemo-mechanical preparation and obturation, all were done in two or three visits Receives: Procedure: ROOT CANAL TREATMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprision of Post-Operative pain Frequency
After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on VAS scale was considered as absence of pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start9 Mar 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- : This study was a randomized controlled trial conducted at Department of Operative Dentistry, Fatima Memorial Hospital, Lahore, over a period of six months. A total of 302 patients presented with pulp necrosis in mandibular and maxillary first and second molar were included in this study and divided in two groups of 151. RCT of Group A patients was performed in single visit and RCT of group B patients was performed in multiple visits
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hma Tanvir, Fatima Memorial Hospital
- Investigators
- Huma Tanvir, BDS, Principal investigator, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944589
- Sponsor's protocol ID
- 14345
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain Frequency in Non-vital Teeth After Single Visit Root Canal Versus Multiple Visit Root Canal Treatment
- ClinicalTrials.gov ID
- NCT04944589
- Acronym / sponsor ID
- 14345
- Conditions
- Pain, Postoperative
- Keywords
- Endodontics, Non-vital teeth, Post-operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 29 Jun 2021 (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 objective of this study is:
- To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
- Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.
Detailed description
METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits.
The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on Visual Analogue Scale (VAS) scale was considered as absence of pain.
The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- : This study was a randomized controlled trial conducted at Department of Operative Dentistry, Fatima Memorial Hospital, Lahore, over a period of six months. A total of 302 patients presented with pulp necrosis in mandibular and maxillary first and second molar were included in this study and divided in two groups of 151. RCT of Group A patients was performed in single visit and RCT of group B patients was performed in multiple visits
| Arm | Type | Receives |
|---|---|---|
| single visit root canal treatment(RCT) | Experimental | Procedure: ROOT CANAL TREATMENTRCT(ROOT CANAL TREATMENT) of this group was performed in single visit including access cavity, chemo-mechanical preparation and obturation, all were done in one visit |
| Multiple visit root canal treatment(RCT) | Experimental | Procedure: ROOT CANAL TREATMENTRCT(ROOT CANAL TREATMENT) of this group was performed in multiple visit including access cavity, chemo-mechanical preparation and obturation, all were done in two or three visits |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients within age range 20-40 years.
Key exclusion criteria (5 listed)
- • Any contraindication to local anesthesia, e.g. known allergy
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 |
|---|---|---|
| ROOT CANAL TREATMENTClinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics. | Procedure or surgery | Multiple visit root canal treatment(RCT), single visit root canal treatment(RCT) |
Primary outcome
Comprision of Post-Operative pain Frequency
Time frame: 6 months
After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on VAS scale was considered as absence of pain
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 29 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Huma Tanvir, BDS principal investigator
Fatima Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROOT CANAL TREATMENT in people with Pain, Postoperative, run by Fatima Memorial Hospital at 1 site in Pakistan.
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 5 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 29 Jun 2021. 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 Pakistan. 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?
Comprision of Post-Operative pain Frequency (time frame: 6 months). 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 29 Jun 2021.