NCT05687760

Brief Summary

the aim of the study is to compare the effect of bromelain vs calcium hydroxide as intracanal medication on intensity of pain and bacterial load in necrotic single lower premolars

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

December 21, 2022

Last Update Submit

January 15, 2023

Conditions

Intracanal MedicationBromelainCalcium HydroxideBacterial Load Reduction

Outcome Measures

Primary Outcomes (4)

  • postoperative pain intensity

    measured using Numerical rating scale

    6 hours post-instrumentation

  • postoperative pain intensity

    measured using numerical rating scale

    12 hours post-instrumentation

  • postoperative pain intensity

    measured using numerical rating scale

    24 hours post-instrumentation

  • postoperative pain intensity

    measured using numerical rating scale

    48 hours post-instrumentation

Secondary Outcomes (7)

  • bacterial load reduction

    immediately after access preparation and pre- instrumentation.

  • enterococcal bacterial count

    immediately after access preparation and pre- instrumentation.

  • bacterial load reduction

    immediately after instrumentation

  • enterococcal bacterial count

    immediately after instrumentation

  • bacterial load reduction

    1 week after intracanal medicament placement

  • +2 more secondary outcomes

Study Arms (2)

calcium hydroxide arm

ACTIVE COMPARATOR

intracanal medication of calcium hydroxide paste

Drug: Calcium hydroxide

bromelain arm

EXPERIMENTAL

intracanal medication of bromelain paste (Bromelain powder with enzymatic activity of 2400 Gelatin digestion unit per Gram was mixed with saline in 1:1 proportion 1 g powder was mixed with 1 ml distilled water)

Biological: bromelain

Interventions

bromelainBIOLOGICAL

is a proteolytic enzyme derived from the stem part and fruit of pineapples (Ananas comosus).used as intracanal medication

bromelain arm
Calcium hydroxideDRUG

calcium hydroxide

calcium hydroxide arm

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic disease (ASA I or II) .
  • Age between 25-50 years old.
  • Males \& Females.
  • Patients who can understand pain scale and can sign the informed consent.
  • Mandibular Single rooted premolars, having single root canal:
  • Diagnosed clinically with pulp necrosis.
  • Absence of spontaneous pulpal pain.
  • Positive pain on percussion denoting apical periodontitis.
  • Slight widening in the periodontal membrane space with or without periapical radiolucency radiographically.
  • Normal occlusal contact with opposing teeth

You may not qualify if:

  • Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
  • Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  • If antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception.
  • Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
  • Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
  • Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
  • No restorability: Hopeless tooth.
  • Immature teeth.
  • Radiographic evidence of external or internal root resorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BromelainsCalcium Hydroxide

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidasesHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 18, 2023

Study Start

February 10, 2023

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01