Postoperative PainEarly Phase 1NCT05816772
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
A Early Phase 1 study testing Endosequence Bio ceramic Sealer and Sealapex Calcium hydroxide Based Sealer in people with Postoperative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Background: Root canal therapy is a well documented and established method to eliminate inflamed pulp and reduce pain, but the procedure itself is associated with postoperative discomfort, ranging from 1.2%-82.9% in different studies. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Endosequence Bio ceramic Sealer and Sealapex Calcium hydroxide Based Sealer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2022to 3 Apr 2023
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who need root canal treatment of minimum one tooth.
- Patients between 18 years to 60 years of age.
- Single rooted tooth with a single (type I canal configuration according to vertucci) canal including mandibular and maxillary incisors, canine and premolars except maxillary first premolar.
- Tooth is diagnosed with symptomatic Irreversible Pulpitis.
- The periapical index score is from 2 to 3 according to Orstavik et al.
Who cannot join
- • Medically compromised patients.
- Patient rejecting to participate in study.
- Inability to achieve the full length of canal.
- Teeth with periodontal disease (probing depth >4mm).
- Complication during treatment (separation of file, ledge formation, etc.).
- Pulpal necrosis, chronic apical periodontitis, acute and chronic periodontal abcess.
- Any swelling or draining sinus.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow International Dental College (Defence campus)
Karachi, Sindh
About this study
Official title: Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment: A Randomized Clinical Trial.
Background:
Root canal therapy is a well documented and established method to eliminate inflamed pulp and reduce pain, but the procedure itself is associated with postoperative discomfort, ranging from 1.2%-82.9% in different studies. There are several treatment-related factors that are found to be linked to postoperative pain, including gauging canal length with apex locator, the choice of instrumentation, number of visits and the root canal sealer being used. When used in the root canal obturation, an endodontic sealer may affect periodontal tissue through apical foramina, lateral canals, or leaching and can hinder the healing process. Thus, the local inflammation caused by root canal obturation may result in post-operative pain. The extent of inflammatory response depends on multiple factors, which also include the content of the sealer.
Read more
The reason of using calcium hydroxide sealers is driven by their potential for tissue healing and antibacterial properties. Antimicrobial effects of Calcium Hydroxide is attributed to the presences and numbers of hydroxyl groups which cause pH to increase as high as 12.5.
The elevated pH levels also encourage repair and bone ossification, thus helping in healing. Hard tissue formation which is associated with calcium hydroxide's alkaline nature occurs due to inhibition of lactic acid secreted by osteoclast, activation of Alkaline phosphatase and calcium-dependent ATP.
Bioceramic sealers are considered to provide better results for root canals treatments by promoting osteoblastic differentiation and by releasing bioactive substances. Cytotoxicity of bioceramics is lower in comparision of resin-based sealers. Less cytotoxicity also lowers the potential of irritation and inflammation of periodontal tissues, thus leading to reduced levels of associated post-operative pain. Very limited data is available on the comparison between calcium hydroxide and bioceramic sealer.
Objectives:
- To compare pre and postoperative pain within each group(calcium hydroxide sealer and Bioceramic sealer).
- Compare postoperative pain between calcium hydroxide sealer and Bioceramic sealer groups.
- To observe the effect of type of tooth and patient demographics on postoperative pain in each group.
Methods:
After taking consent, A total of 80 patients with symptomatic irreversible pulpitis will be randomly assigned to one of two groups in this 6-month In-Vitro Single-Blinded Randomized Clinical Study. Group A will receive calcium hydroxide as an endodontic sealer and B will receive bioceramic sealer respectively. Recordings of postoperative pain will be obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale by the Researcher.
SPSSv.24 will be used to analyze the data with the level of significance set at p < 0.05. For comparison of VAS scores, Paired Sample t-test//Wilcoxon-signed rank test will be used. Independent sample-test/Mann-Whitney U-test will be used to assess the differences in VAS pain scores between the groups. The chi-square test will be used to determine the frequency of tooth types among the tested materials and the distribution of patients among VAS scores.
- Conditions
- Postoperative Pain
- Being tested
- Endosequence Bio ceramic Sealer, Sealapex Calcium hydroxide Based Sealer
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endosequence Bio ceramic SealerDrug
Brasseler,USA, a nano-particulate injectable premixed bioceramic sealer that contains Calcium Silicates, Calcium Phosphate, Calcium Hydroxide and Zirconium Oxide
Sealapex Calcium hydroxide Based SealerDrug
KERR Dental, an original eugenol-free root canal sealant based on calcium hydroxide.
| Study group | Role | What they receive |
|---|---|---|
| Endosequence Bio ceramic based Sealer | Experimental | Sealer was introduced into the canal by coating the master gutta-percha point (Endosequence, Brasseler USA, Gutta Percha ) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale. Receives: Drug: Endosequence Bio ceramic Sealer |
| Sealapex calcium hydroxide based sealer | Active comparator | Sealer was introduced into the canal by coating the master gutta-percha point (Dentsply Sirona, GuttaPercha Conform fit) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale. Receives: Drug: Sealapex Calcium hydroxide Based Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at Day 0 before the application of experimental agents.
Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate pain) and 7-10 ( Severe pain)
Measured: Before application of experimental agents (Day 0)
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 24 hour after the application of experimental agents.
Measured: 24 hour after application of experimental agents
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 48 hour after the application of experimental agents.
Measured: 48 hour after application of experimental agents
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 72 hour after the application of experimental agents.
Measured: 72 hour after application of experimental agents
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 7 Days after the application of experimental agents.
Measured: 7 Days after application of experimental agents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start25 Oct 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, syed hasan shaharyar, Dow University of Health Sciences
- Investigators
- Syed Hasan Shaharyar, BDS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816772
- Sponsor's protocol ID
- HShaharyar
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05816772
- Acronym / sponsor ID
- HShaharyar
- Conditions
- Postoperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 18 Apr 2023 (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.
Background:
Root canal therapy is a well documented and established method to eliminate inflamed pulp and reduce pain, but the procedure itself is associated with postoperative discomfort, ranging from 1.2%-82.9% in different studies. There are several treatment-related factors that are found to be linked to postoperative pain, including gauging canal length with apex locator, the choice of instrumentation, number of visits and the root canal sealer being used. When used in the root canal obturation, an endodontic sealer may affect periodontal tissue through apical foramina, lateral canals, or leaching and can hinder the healing process. Thus, the local inflammation caused by root canal obturation may result in post-operative pain. The extent of inflammatory response depends on multiple factors, which also include the content of the sealer.
The reason of using calcium hydroxide sealers is driven by their potential for tissue healing and antibacterial properties. Antimicrobial effects of Calcium Hydroxide is attributed to the presences and numbers of hydroxyl groups which cause pH to increase as high as 12.5.
The elevated pH levels also encourage repair and bone ossification, thus helping in healing. Hard tissue formation which is associated with calcium hydroxide's alkaline nature occurs due to inhibition of lactic acid secreted by osteoclast, activation of Alkaline phosphatase and calcium-dependent ATP.
Bioceramic sealers are considered to provide better results for root canals treatments by promoting osteoblastic differentiation and by releasing bioactive substances. Cytotoxicity of bioceramics is lower in comparision of resin-based sealers. Less cytotoxicity also lowers the potential of irritation and inflammation of periodontal tissues, thus leading to reduced levels of associated post-operative pain. Very limited data is available on the comparison between calcium hydroxide and bioceramic sealer.
Objectives:
- To compare pre and postoperative pain within each group(calcium hydroxide sealer and Bioceramic sealer).
- Compare postoperative pain between calcium hydroxide sealer and Bioceramic sealer groups.
- To observe the effect of type of tooth and patient demographics on postoperative pain in each group.
Methods:
After taking consent, A total of 80 patients with symptomatic irreversible pulpitis will be randomly assigned to one of two groups in this 6-month In-Vitro Single-Blinded Randomized Clinical Study. Group A will receive calcium hydroxide as an endodontic sealer and B will receive bioceramic sealer respectively. Recordings of postoperative pain will be obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale by the Researcher.
SPSSv.24 will be used to analyze the data with the level of significance set at p < 0.05. For comparison of VAS scores, Paired Sample t-test//Wilcoxon-signed rank test will be used. Independent sample-test/Mann-Whitney U-test will be used to assess the differences in VAS pain scores between the groups. The chi-square test will be used to determine the frequency of tooth types among the tested materials and the distribution of patients among VAS scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endosequence Bio ceramic based Sealer | Experimental | Drug: Endosequence Bio ceramic SealerSealer was introduced into the canal by coating the master gutta-percha point (Endosequence, Brasseler USA, Gutta Percha ) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale. |
| Sealapex calcium hydroxide based sealer | Active comparator | Drug: Sealapex Calcium hydroxide Based SealerSealer was introduced into the canal by coating the master gutta-percha point (Dentsply Sirona, GuttaPercha Conform fit) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who need root canal treatment of minimum one tooth.
- Patients between 18 years to 60 years of age.
- Single rooted tooth with a single (type I canal configuration according to vertucci) canal including mandibular and maxillary incisors, canine and premolars except maxillary first premolar.
- Tooth is diagnosed with symptomatic Irreversible Pulpitis.
- The periapical index score is from 2 to 3 according to Orstavik et al.
Key exclusion criteria (7 listed)
- • Medically compromised patients.
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 |
|---|---|---|
| Endosequence Bio ceramic SealerBrasseler,USA, a nano-particulate injectable premixed bioceramic sealer that contains Calcium Silicates, Calcium Phosphate, Calcium Hydroxide and Zirconium Oxide | Drug | Endosequence Bio ceramic based Sealer |
| Sealapex Calcium hydroxide Based SealerKERR Dental, an original eugenol-free root canal sealant based on calcium hydroxide. | Drug | Sealapex calcium hydroxide based sealer |
Primary outcome
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Time frame: Before application of experimental agents (Day 0)
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at Day 0 before the application of experimental agents. Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate pain) and 7-10 ( Severe pain)
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Time frame: 24 hour after application of experimental agents
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 24 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Time frame: 48 hour after application of experimental agents
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 48 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Time frame: 72 hour after application of experimental agents
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 72 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Time frame: 7 Days after application of experimental agents
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 7 Days after the application of experimental agents.
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 18 Apr 2023.
- 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.
Syed Hasan Shaharyar, BDS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Endosequence Bio ceramic Sealer and Sealapex Calcium hydroxide Based Sealer in people with Postoperative Pain, run by Dow University of Health Sciences 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 5 inclusion and 7 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 18 Apr 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment. (time frame: Before application of experimental agents (Day 0)). The study lists 5 primary outcomes in all. 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 18 Apr 2023.