NCT03591172

Brief Summary

this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.

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
75

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 19, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

June 26, 2018

Last Update Submit

July 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-operative pain: Visual analogue scale

    post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.

    1 year

Secondary Outcomes (3)

  • periapical healing

    1 year

  • sensitivity

    1 year

  • survival

    1 year

Study Arms (3)

propolis

EXPERIMENTAL

natural antibacterial, anti-inflammatory irrigation solution

Drug: Propolis

Nano-propolis

EXPERIMENTAL

natural antibacterial, anti-inflammatory irrigation solution

Drug: Nano-propolis

saline

ACTIVE COMPARATOR

sodium chloride irrigation solution

Drug: saline

Interventions

Using propolis as a final irrigation in revascularization

Also known as: natural irrigant
propolis

Using Nano-propolis as a final irrigation in revasculariztion

Also known as: Natural irrigant
Nano-propolis
salineDRUG

Using saline as a final irrigation in revasculariztion

Also known as: sodium chloride
saline

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • mature teeth.
  • teeth with periapical periodontitis.
  • Maxillary anterior teeth
  • Patients should be free from any systemic disease
  • Patients who will agree to the consent and will commit to follow-up period.

You may not qualify if:

  • Patients with immature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PropolisSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex MixturesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 19, 2018

Study Start

September 1, 2018

Primary Completion

November 1, 2018

Study Completion

September 1, 2019

Last Updated

July 19, 2018

Record last verified: 2018-05