Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

NCT02921165 | Completed Phase 4

• 1 other identifier: AgaKhanUniversity
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to determine the beneficial effect of mouth rinses, both topical analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription of post-operative pain killers on the progress of socket healing following routine dental extraction.

Conditions

Periodontitis; Dental Caries; Hypertension

Keywords

tooth extraction; tooth socket healing; hypertension; rinses

Outcome Measures

Primary Outcomes (1)

• Number of participants with unhealed extraction socket

  Number of participants with unhealed extraction socket at 7th day

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)

Drug: analgesic mouth rinses (dissolved Aspirin)

Group 2

EXPERIMENTAL

Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)

Drug: analgesic mouth rinses (dissolved Aspirin)

Group 3

EXPERIMENTAL

Non Hypertensive Intervention: On normal saline rinses.

Drug: Normal saline rinses.

Interventions

analgesic mouth rinses (dissolved Aspirin) DRUG

Group 1 and Group 2 patients will be prescribed analgesic mouth rinses (dissolved Aspirin) twice daily along with the standard prescription of analgesics and antibiotics.

Also known as: water dissolved aspirin rinse

Group 1; Group 2

Normal saline rinses. DRUG

Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.

Also known as: warm saline rinses, salt water rinses

Group 3

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives.

You may not qualify if:

• Subjects requiring surgical tooth extraction involving bone removal and suturing, uncontrolled systemic disorders (diabetes mellitus, hypertension, blood coagulopathies, metabolic bone disorders), on platelet aggregation therapy or warfarin (anticoagulants) or bisphosphonate therapy.

Sponsors & Collaborators

• Aga Khan University: lead

MeSH Terms

Conditions

Periodontitis; Dental Caries; Hypertension

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rabia Ali, BDS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Farhan Raza Kahn, FCPS

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rabia Ali

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 3, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share