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Completed

NCT Number: NCT03723980

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dow International Dental College

Karachi, Sindh, 75500, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
  • Teeth with favorable root morphology.
  • Teeth with closed apex.

Exclusion criteria

  • Teeth with PAI index 1 and 5.
  • Patients who are on antibiotics.
  • Patient with recent trauma to the jaw.
  • Teeth with open apex
  • Multi-rooted teeth.
  • Vital teeth.
  • Non-restorable teeth.
  • Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
  • Teeth associated with soft tissue abscess or swelling.
  • Teeth with external or internal root resorption
  • Re-treatment cases.
  • Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
  • Teeth requiring endodontic surgery.
  • Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
  • Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
  • Patients allergic to bee pollen or honey products.

Treatment and study plan

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.

Other names: Bee glue

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.

Primary outcomes

  1. Pain Intensity Measure: Visual Analogue Pain Scale

    Time frame: 4 hours, 12 hours, day 2, day 3 and day 4

    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)

Secondary outcomes

  1. Acute Increase in Pain Score (Acute Exacerbation of Pain)

    Time frame: 4 hours, 12 hours, day 2, day 3, and day 4

    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"

  2. Difference of Pain Score Between Different Time Intervals

    Time frame: 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.

Other outcomes

  1. Difference of Pain Scores Between Males and Females

    Time frame: 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).

  2. Difference of Pain Scores Between Different Age Groups

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Juzer Shabbir Saifee

Other

Collaborators

  • Dow University of Health Sciences

Registry information

Official study title

Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2018
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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