Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing

NCT ID: NCT03130153

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tooth Extraction Site Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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hypertensives on Aspirin mouthwash

Group Type EXPERIMENTAL

Aspirin Powder

Intervention Type DRUG

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

non-hypertensives on Aspirin mouthwash

Group Type ACTIVE_COMPARATOR

Aspirin Powder

Intervention Type DRUG

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

hypertensives on Saline mouthwash

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Aspirin Powder

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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Acetyl salicylic acid 0.9% NaCl Saline

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Farhan Raza Khan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farhan R Khan, BDS MS FCPS

Role: STUDY_DIRECTOR

AKU

Locations

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Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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3425-Sur-ERC-14

Identifier Type: -

Identifier Source: org_study_id

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