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Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

Primary Purpose

Periodontitis, Dental Caries, Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
analgesic mouth rinses (dissolved Aspirin)
Normal saline rinses.
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring tooth extraction, tooth socket healing, hypertension, rinses

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

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

    Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)

    Non Hypertensive Intervention: On normal saline rinses.

    Outcomes

    Primary Outcome Measures

    Number of participants with unhealed extraction socket

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2016
    Last Updated
    September 29, 2016
    Sponsor
    Aga Khan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02921165
    Brief Title
    Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing
    Official Title
    Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-hypertensive Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Hypertension is a highly prevalent cardiovascular disease, which affects over 1 billion people worldwide. It varies with age, race, education and so forth.1 The National Health Survey of Pakistan estimated that hypertension affects 18% of adults and 33% of adults are above 45 years old.2It is a common disease encountered in dental setting. Its wide spreading, terrible consequences, and life-long treatment require an attentive approach by dentists. Knowledge of hypertension is important for dentists especially for risk assessment for dental treatment. This may lead to improved monitoring and treatment. Dental treatment in hypertensive patients necessitates special attention, because any stressful procedure may increase blood pressure and trigger acute complications such as cardiac arrest or stroke. Extractions are usually done for teeth which are not salvageable. Dentists routinely advice use of warm saline rinses to help in healing of post extraction socket. But for hypertensive patients this recommendation is potentially harmful There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Moreover, advantage of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Dental Caries, Hypertension
    Keywords
    tooth extraction, tooth socket healing, hypertension, rinses

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    Non Hypertensive Intervention: On normal saline rinses.
    Intervention Type
    Drug
    Intervention Name(s)
    analgesic mouth rinses (dissolved Aspirin)
    Other Intervention Name(s)
    water dissolved aspirin rinse
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline rinses.
    Other Intervention Name(s)
    warm saline rinses, salt water rinses
    Intervention Description
    Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.
    Primary Outcome Measure Information:
    Title
    Number of participants with unhealed extraction socket
    Time Frame
    Number of participants with unhealed extraction socket at 7th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rabia Ali, BDS
    Organizational Affiliation
    Aga Khan University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Farhan Raza Kahn, FCPS
    Organizational Affiliation
    Aga Khan University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

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