Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing

June 27, 2018 updated by: Farhan Raza Khan, Aga Khan University

Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-Hypertensive Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To compare the post dental extraction healing among subjects who took simple analgesic tablets dissolved in water versus those who used saline rinses post operatively.

Methods: A study will be done among patients who underwent dental extractions at AKHSP dental clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth among 20-70 years old in either gender will be included.

In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses or dissolved Aspirin for 5 days, respectively.

The outcome (healing of the extraction socket) will be evaluated 7 days from the day of extraction on an ordinal scale.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypertensives on Aspirin mouthwash
Drug: Aspirin Powder
Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.
Other Names:
  • Acetyl salicylic acid
Active Comparator: non-hypertensives on Aspirin mouthwash
Drug: Aspirin Powder
Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.
Other Names:
  • Acetyl salicylic acid
Active Comparator: hypertensives on Saline mouthwash
Drug: Normal saline
Normal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects.
Other Names:
  • Saline
  • 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of the extraction socket
Time Frame: Seven days from the day of extraction
  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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Study Director: Farhan R Khan, BDS MS FCPS, AKU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 15, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3425-Sur-ERC-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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