NCT03130153

Brief Summary

There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

April 23, 2017

Last Update Submit

June 27, 2018

Conditions

Tooth Extraction Site Healing

Outcome Measures

Primary Outcomes (1)

  • Healing of the extraction socket

    1. = "healed or healing well" 2. = "incomplete healing but progressing" 3. = "poorly healed open margins and readily bleeding"

    Seven days from the day of extraction

Study Arms (3)

hypertensives on Aspirin mouthwash

EXPERIMENTAL
Drug: Aspirin Powder

non-hypertensives on Aspirin mouthwash

ACTIVE COMPARATOR
Drug: Aspirin Powder

hypertensives on Saline mouthwash

ACTIVE COMPARATOR
Drug: Normal saline

Interventions

Aspirin PowderDRUG

Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.

Also known as: Acetyl salicylic acid
hypertensives on Aspirin mouthwashnon-hypertensives on Aspirin mouthwash
Normal salineDRUG

Normal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects.

Also known as: 0.9% NaCl, Saline
hypertensives on Saline mouthwash

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Carious, periodontally mobile, traumatized or broken down teeth needing extraction
  • Age 20-70 years, both genders

You may not qualify if:

  • Diabetes
  • Osteoporosis, metabolic bone disease etc.
  • Radiation therapy or chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Interventions

Saline SolutionSodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Farhan R Khan, BDS MS FCPS

    AKU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

January 1, 2016

Primary Completion

July 15, 2017

Study Completion

December 31, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)