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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN66816132 | Registry Identifier | SPRINGER NATURE |
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| Name | Class |
|---|---|
| Dow University of Health Sciences | OTHER |
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This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.
Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.
Calcium hydroxide is a synthetic medication which is antibacterial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group or Group I or Calcium hydroxide Group | Active Comparator |
| |
| Experimental Group or Group II or Propolis Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis | Drug | it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measure: Visual Analogue Pain Scale | Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score) | 4 hours, 12 hours, day 2, day 3 and day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Increase in Pain Score (Acute Exacerbation of Pain) | An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval Information about the Visual Analogue Scale:
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Pain Scores Between Males and Females | Information about Visual Analogue Scale for rating pain scores:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juzer S Saifee | Dow University of Health Sciences | Principal Investigator |
| Fazal R Qazi | Dow University of Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow International Dental College | Karachi | Sindh | 75500 | Pakistan |
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Start of recruitment : 1st october 2017 End of Recruitment: 24th april 2018
location: Pakistan; Karachi; Dow-International dental college, Operative Dentistry; out-patient department.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group or Group I or Calcium Hydroxide Group | Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. |
| FG001 | Experimental Group or Group II or Propolis Group | Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group or Group I or Calcium Hydroxide Group | Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity Measure: Visual Analogue Pain Scale | Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score) | Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed | Posted | Mean | Standard Deviation | score on a scale | 4 hours, 12 hours, day 2, day 3 and day 4 |
4 hours, 12 hours, day 2, day 3, and day 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group or Group I or Calcium Hydroxide Group | Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flare-up | General disorders | Systematic Assessment | Increase of 20 or more pain score points from pain score of previous time interval on Visual Analogue Scale |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juzer Shabbir Saifee | Dow University of Health Sciences | 92-333-2352134 | dr.juzer.shabbir@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 14, 2017 | Oct 25, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| D002126 | Calcium Hydroxide |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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|
|
| Calcium Hydroxide | Drug | it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. |
|
| 4 hours, 12 hours, day 2, day 3, and day 4 |
| Difference of Pain Score Between Different Time Intervals | Visual Analogue Pain Score information:
this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4. the comparison of mean pain scores of different time intervals will be made. | 4 hours, 12 hours, day 2, day 3, and day 4 |
| 4 hours, 12 hours, day 2, day 3, and day 4 |
| Difference of Pain Scores Between Different Age Groups | Information about Visual Analogue Scale for rating pain scores:
| 4 hours, 12 hours, day 2, day 3, and day 4 |
| BG001 |
| Experimental Group or Group II or Propolis Group |
Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Number of participants |
|
| Pre-operative pain score from 0 (no pain) to 100 (worst pain) on Visual Analogue Scale | Mean | Standard Deviation | units on a scale |
|
| Type of single-rooted teeth | Number | Number of teeth |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Control Group or Group I or Calcium Hydroxide Group | Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. |
| OG001 | Experimental Group or Group II or Propolis Group | Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. |
|
|
|
| Secondary | Acute Increase in Pain Score (Acute Exacerbation of Pain) | An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval Information about the Visual Analogue Scale:
| Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed | Posted | Count of Participants | Participants | 4 hours, 12 hours, day 2, day 3, and day 4 |
|
|
|
| Secondary | Difference of Pain Score Between Different Time Intervals | Visual Analogue Pain Score information:
this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4. the comparison of mean pain scores of different time intervals will be made. | Posted | Mean | Standard Error | score on a scale | 4 hours, 12 hours, day 2, day 3, and day 4 |
|
|
|
|
| Other Pre-specified | Difference of Pain Scores Between Males and Females | Information about Visual Analogue Scale for rating pain scores:
| Posted | Mean | Standard Deviation | score on a scale | 4 hours, 12 hours, day 2, day 3, and day 4 |
|
|
|
|
| Other Pre-specified | Difference of Pain Scores Between Different Age Groups | Information about Visual Analogue Scale for rating pain scores:
| Posted | Mean | Standard Deviation | score on a scale | 4 hours, 12 hours, day 2, day 3, and day 4 |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Experimental Group or Group II or Propolis Group | Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. | 0 | 40 | 0 | 40 | 6 | 40 |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| 12 hours |
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Total |
|
| Pain score difference; 12 hours - day 2 |
|
| Pain score difference; day 2 - day 3 |
|
| Pain score difference; day 3 - day 4 |
|
| 0.448 |
The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours. Threshold for statistical significance= <0.05 |
| Mean Difference (Net) |
| 2.33 |
| Standard Error of the Mean |
| 3 |
| 2-Sided |
| 95 |
| Other |
| ANOVA | 0.056 | The calculated p value is for the difference between time intervals of 12 hours and day 2 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 5.88 | Standard Error of the Mean | 3 | 2-Sided | 95 | Other |
| ANOVA | 0.760 | The calculated p value is for the difference between time intervals of day 2 and day 3 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 0.94 | Standard Error of the Mean | 3 | 2-Sided | 95 | Other |
| ANOVA | 0.828 | The calculated p value is for the difference between time intervals of day 3 and day 4 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 0.67 | Standard Error of the Mean | 3 | 2-Sided | 95 | Other |
| ANOVA | 0.000 | The calculated p value is for the difference between pre-operative time interval and 4 hours time interval Threshold for statistical significance= <0.05 | Mean Difference (Net) | 11.80 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | Other |
| ANOVA | 0.605 | The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours Threshold for statistical significance= <0.05 | Mean Difference (Net) | -1.54 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | Other |
| ANOVA | 0.80 | The calculated p value is for the difference between time intervals of 12 hours and day 2 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 5.23 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | Other |
| ANOVA | 0.574 | The calculated p value is for the difference between time intervals of day 2 and day 3 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 1.69 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | Other |
| ANOVA | 0.796 | The calculated p value is for the difference between time intervals of day 3 and day 4 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 0.77 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | Other |
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| 0.94 |
The p-value calculated is for pain score difference at 12 hours Threshold for statistical significance= <0.05 |
| Mean Difference (Net) |
| 2.8 |
| 2-Sided |
| Other |
| Wilcoxon (Mann-Whitney) | 0.035 | The p-value calculated is for pain score difference at Day 2 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 5.5 | 2-Sided | Other |
| Wilcoxon (Mann-Whitney) | 0.023 | The p-value calculated is for pain score difference at Day 3 Threshold for statistical significance= <0.05 | Mean Difference (Net) | 4.4 | 2-Sided | Other |
| Wilcoxon (Mann-Whitney) | 0.020 | The p-value calculated is for pain score difference at Day 4. Threshold for statistical significance= <0.05 | Median Difference (Net) | 4.3 | 2-Sided | Other |
| Mean pain score; 12 hours |
|
| Mean pain score; day 2 |
|
| Mean pain score; day 3 |
|
| Mean pain score; day 4 |
|
| 0.36 |
The p-value calculated is for pain score difference at 12 hours Threshold for statistical significance= <0.05 |
| Other |
| Kruskal-Wallis | 0.13 | The p-value calculated is for pain score difference at day 2 Threshold for statistical significance= <0.05 | Other |
| Kruskal-Wallis | 0.55 | The p-value calculated is for pain score difference at day 3 Threshold for statistical significance= <0.05 | Other |
| Kruskal-Wallis | 0.17 | The p-value calculated is for pain score difference at day 4 Threshold for statistical significance= <0.05 | Other |