Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing

Early Phase 1

Completed

• Conditions: Tooth Extraction Site Healing
• Interventions: Drug: Normal saline; Drug: Aspirin Powder

• Registration Number: NCT03130153
• Lead Sponsor: Aga Khan University

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.

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 Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Primary Completion: 2017-07-15
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypertensives on Saline mouthwash	Normal saline	-
hypertensives on Aspirin mouthwash	Aspirin Powder	-
non-hypertensives on Aspirin mouthwash	Aspirin Powder	-

Primary Outcome Measures

Name	Time	Method
Healing of the extraction socket	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"

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sind, Pakistan