Trial Outcomes & Findings for Role of Propolis Paste in Preventing Pain After Root Canal Treatment. (NCT NCT03723980)

NCT ID: NCT03723980

Last Updated: 2019-06-06

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

4 hours, 12 hours, day 2, day 3 and day 4

Results posted on

2019-06-06

Participant Flow

Start of recruitment : 1st october 2017 End of Recruitment: 24th april 2018 location: Pakistan; Karachi; Dow-International dental college, Operative Dentistry; out-patient department.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
40
40
Overall Study
COMPLETED
33
35
Overall Study
NOT COMPLETED
7
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Propolis Paste in Preventing Pain After Root Canal Treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group or Group I or Calcium Hydroxide Group
n=40 Participants
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.
Experimental Group or Group II or Propolis Group
n=40 Participants
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.
Total
n=80 Participants
Total of all reporting groups
Age, Continuous
33.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
33.2 years
STANDARD_DEVIATION 6 • n=7 Participants
33.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
Age, Customized
Age Range · 20 to 24
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Age, Customized
Age Range · 25 to 29
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Age, Customized
Age Range · 30 to 34
6 Participants
n=5 Participants
13 Participants
n=7 Participants
19 Participants
n=5 Participants
Age, Customized
Age Range · 35 to 40
23 Participants
n=5 Participants
19 Participants
n=7 Participants
42 Participants
n=5 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
22 Participants
n=7 Participants
50 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
18 Participants
n=7 Participants
30 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
40 Participants
n=5 Participants
40 Participants
n=7 Participants
80 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Pakistan
40 Number of participants
n=5 Participants
40 Number of participants
n=7 Participants
80 Number of participants
n=5 Participants
Pre-operative pain score from 0 (no pain) to 100 (worst pain) on Visual Analogue Scale
13.1 units on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
18.1 units on a scale
STANDARD_DEVIATION 12.4 • n=7 Participants
15.6 units on a scale
STANDARD_DEVIATION 17.5 • n=5 Participants
Type of single-rooted teeth
Maxillary Central Incisor
4 Number of teeth
n=5 Participants
2 Number of teeth
n=7 Participants
6 Number of teeth
n=5 Participants
Type of single-rooted teeth
Maxillary Lateral Incisor
4 Number of teeth
n=5 Participants
4 Number of teeth
n=7 Participants
8 Number of teeth
n=5 Participants
Type of single-rooted teeth
Maxillary Canine
8 Number of teeth
n=5 Participants
7 Number of teeth
n=7 Participants
15 Number of teeth
n=5 Participants
Type of single-rooted teeth
Maxillary Second Premolar
6 Number of teeth
n=5 Participants
14 Number of teeth
n=7 Participants
20 Number of teeth
n=5 Participants
Type of single-rooted teeth
Mandibular Lateral Incisor
3 Number of teeth
n=5 Participants
0 Number of teeth
n=7 Participants
3 Number of teeth
n=5 Participants
Type of single-rooted teeth
Mandibular Canine
1 Number of teeth
n=5 Participants
2 Number of teeth
n=7 Participants
3 Number of teeth
n=5 Participants
Type of single-rooted teeth
Mandibular First Premolar
4 Number of teeth
n=5 Participants
5 Number of teeth
n=7 Participants
9 Number of teeth
n=5 Participants
Type of single-rooted teeth
Mandibular Second Premolar
10 Number of teeth
n=5 Participants
6 Number of teeth
n=7 Participants
16 Number of teeth
n=5 Participants

PRIMARY outcome

Timeframe: 4 hours, 12 hours, day 2, day 3 and day 4

Population: 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

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)

Outcome measures

Outcome measures
Measure
Control Group or Group I or Calcium Hydroxide Group
n=33 Participants
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.
Experimental Group or Group II or Propolis Group
n=35 Participants
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.
Age Group; 30 to 34
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group
Age Group; 35 to 40
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group
Pain Intensity Measure: Visual Analogue Pain Scale
4 hours
11.8 score on a scale
Standard Deviation 18.7
8.8 score on a scale
Standard Deviation 11.1
Pain Intensity Measure: Visual Analogue Pain Scale
Day 2
3.5 score on a scale
Standard Deviation 7.7
5.1 score on a scale
Standard Deviation 9.2
Pain Intensity Measure: Visual Analogue Pain Scale
Day 3
2.6 score on a scale
Standard Deviation 6.4
3.4 score on a scale
Standard Deviation 6.8
Pain Intensity Measure: Visual Analogue Pain Scale
Day 4
1.9 score on a scale
Standard Deviation 4.7
2.7 score on a scale
Standard Deviation 7.3
Pain Intensity Measure: Visual Analogue Pain Scale
12 hours
9.4 score on a scale
Standard Deviation 16.7
10.3 score on a scale
Standard Deviation 13.3

SECONDARY outcome

Timeframe: 4 hours, 12 hours, day 2, day 3, and day 4

Population: 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

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: * it consists of pain score from 0 to 100. * The higher the pain score; the worse the pain * An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as "flare-up"

Outcome measures

Outcome measures
Measure
Control Group or Group I or Calcium Hydroxide Group
n=33 Participants
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.
Experimental Group or Group II or Propolis Group
n=35 Participants
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.
Age Group; 30 to 34
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group
Age Group; 35 to 40
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group
Acute Increase in Pain Score (Acute Exacerbation of Pain)
4 hours · Flare up
4 Participants
1 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
4 hours · No flare up
29 Participants
34 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
12 hours · Flare up
0 Participants
4 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
12 hours · No flare up
33 Participants
31 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 2 · Flare up
0 Participants
1 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 2 · No flare up
33 Participants
34 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 3 · Flare up
0 Participants
0 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 3 · No flare up
33 Participants
35 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 4 · Flare up
0 Participants
0 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Day 4 · No flare up
33 Participants
35 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Total · Flare up
4 Participants
6 Participants
Acute Increase in Pain Score (Acute Exacerbation of Pain)
Total · No flare up
29 Participants
29 Participants

SECONDARY outcome

Timeframe: 4 hours, 12 hours, day 2, day 3, and day 4

Visual Analogue Pain Score information: * pain intensity is measured with this scale * minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100 * higher values represent worse pain and lower values represent lesser pain 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.

Outcome measures

Outcome measures
Measure
Control Group or Group I or Calcium Hydroxide Group
n=33 Participants
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.
Experimental Group or Group II or Propolis Group
n=35 Participants
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.
Age Group; 30 to 34
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group
Age Group; 35 to 40
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group
Difference of Pain Score Between Different Time Intervals
Pain score difference; pre-operative - 4 hours
2.97 score on a scale
Standard Error 3
11.80 score on a scale
Standard Error 2.9
Difference of Pain Score Between Different Time Intervals
Pain score difference; 4 hours - 12 hours
2.33 score on a scale
Standard Error 3
-1.54 score on a scale
Standard Error 2.9
Difference of Pain Score Between Different Time Intervals
Pain score difference; 12 hours - day 2
5.88 score on a scale
Standard Error 3
5.23 score on a scale
Standard Error 2.9
Difference of Pain Score Between Different Time Intervals
Pain score difference; day 2 - day 3
0.94 score on a scale
Standard Error 3
1.69 score on a scale
Standard Error 2.9
Difference of Pain Score Between Different Time Intervals
Pain score difference; day 3 - day 4
0.67 score on a scale
Standard Error 3
0.77 score on a scale
Standard Error 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours, 12 hours, day 2, day 3, and day 4

Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between males and females at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).

Outcome measures

Outcome measures
Measure
Control Group or Group I or Calcium Hydroxide Group
n=25 Participants
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.
Experimental Group or Group II or Propolis Group
n=43 Participants
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.
Age Group; 30 to 34
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group
Age Group; 35 to 40
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group
Difference of Pain Scores Between Males and Females
4 hours
9.8 score on a scale
Standard Deviation 11.9
10.4 score on a scale
Standard Deviation 16.9
Difference of Pain Scores Between Males and Females
12 hours
11.6 score on a scale
Standard Deviation 14.5
8.8 score on a scale
Standard Deviation 15.2
Difference of Pain Scores Between Males and Females
Day 2
7.8 score on a scale
Standard Deviation 11
2.3 score on a scale
Standard Deviation 5.8
Difference of Pain Scores Between Males and Females
Day 3
5.8 score on a scale
Standard Deviation 8.9
1.40 score on a scale
Standard Deviation 4
Difference of Pain Scores Between Males and Females
Day 4
5 score on a scale
Standard Deviation 9.2
0.70 score on a scale
Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours, 12 hours, day 2, day 3, and day 4

Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between different age groups: 20 to 24; 25 to 29; 30 to 34; and 35 to 40 at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).

Outcome measures

Outcome measures
Measure
Control Group or Group I or Calcium Hydroxide Group
n=6 Participants
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.
Experimental Group or Group II or Propolis Group
n=10 Participants
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.
Age Group; 30 to 34
n=17 Participants
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 17 patients. 6 belonged to control group and 11 belonged to experimental group
Age Group; 35 to 40
n=35 Participants
For ease of tabulating results; patients were distributed in 4 groups according to their age: 20 to 24; 25 to 29; 30 to 34; 35 to 40 This age group consisted of total number of 35 patients. 18 belonged to control group and 17 belonged to experimental group
Difference of Pain Scores Between Different Age Groups
Mean pain score; 4 hours
7.1 score on a scale
Standard Deviation 9.1
14.5 score on a scale
Standard Deviation 15.1
14.6 score on a scale
Standard Deviation 21.2
7.4 score on a scale
Standard Deviation 12.1
Difference of Pain Scores Between Different Age Groups
Mean pain score; 12 hours
8.3 score on a scale
Standard Deviation 14.3
12.9 score on a scale
Standard Deviation 17.9
13.6 score on a scale
Standard Deviation 16.3
7.4 score on a scale
Standard Deviation 13.5
Difference of Pain Scores Between Different Age Groups
Mean pain score; day 2
0 score on a scale
Standard Deviation 0
10.6 score on a scale
Standard Deviation 13.1
3.7 score on a scale
Standard Deviation 6.9
3.6 score on a scale
Standard Deviation 7.7
Difference of Pain Scores Between Different Age Groups
Mean pain score; day 3
1.5 score on a scale
Standard Deviation 3.6
4 score on a scale
Standard Deviation 9.6
1.5 score on a scale
Standard Deviation 4.2
3.7 score on a scale
Standard Deviation 6.9
Difference of Pain Scores Between Different Age Groups
Mean pain score; day 4
0 score on a scale
Standard Deviation 0
2.1 score on a scale
Standard Deviation 6.2
0.3 score on a scale
Standard Deviation 1.2
3.7 score on a scale
Standard Deviation 7.6

Adverse Events

Control Group or Group I or Calcium Hydroxide Group

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Experimental Group or Group II or Propolis Group

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Control Group or Group I or Calcium Hydroxide Group
n=40 participants at risk
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.
Experimental Group or Group II or Propolis Group
n=40 participants at risk
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.
General disorders
Flare-up
10.0%
4/40 • 4 hours, 12 hours, day 2, day 3, and day 4
15.0%
6/40 • 4 hours, 12 hours, day 2, day 3, and day 4

Additional Information

Dr. Juzer Shabbir Saifee

Dow University of Health Sciences

Phone: 92-333-2352134

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place