Prevention of Dry Socket by Means of Single Preoperative Antibiotics Compared to Conventional Therapy

NCT03992144 | Completed Phase 2

• 1 other identifier: Tahseen.S.Khooharo
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Background: One of the commonest post-operative complications after tooth extraction is dry socket; it can be defined as postoperative pain in and around the tooth extraction site, which increases in severity at any time between 3rd to 5th post-operative days along with disintegrated blood clot within the tooth extraction socket with or without halitosis. The exact etiology is unclear therefor prevention remains the main beneficial therapy. Various factors are thought to play an important role in etiology of dry socket including, anaerobes, fibrinolysis, traumatic extractions, frequent spiting and rinsing, oral contraceptive pill and smoking. Numerous approaches have been tried for prevention of dry socket; include antiseptic mouthwashes, anti-fibrinolytic agents, antibiotics, intra-socket dressings and medicated packing into the extraction wound for example chlorohexidine mouthwashes, warm saline rinses, gelatin sponges, occlusive dressings and oxidized cellulose sponge. Purpose of the study is to compare the role of single preoperative oral dose of metronidazole with amoxicillin in hindrance of dry socket compared to conventional therapy after removal of mandibular third molar of class 2 impaction. Objectives: To find out effective treatment for prevention of dry socket among preoperative single oral dose of metronidazole and amoxicillin compared to conventional therapy. Methods: A double blind randomized control trial in which patients requiring surgical extraction of lower 3rd molar of class 2 impactions were selected for this study. Patients were randomly divided into 3 groups, one of the groups had received single preoperative oral dose of metronidazole one hour before extraction, second group was treated with single oral dose of amoxicillin an hour before tooth extraction and third group was treated with conventional therapy. Patients were asked to visit on 5th postoperative day or before it in case the pain persist or reoccur.

Conditions

Dry Socket

Keywords

dry socket; metronidazole; amoxicillin; lower 3rd molars

Outcome Measures

Primary Outcomes (1)

• dry socket

  Characteristic of interest: patient complaining of moderate to severe pain in or around the tooth extraction site between 3 to 5 post-operative days. Measuring instruments: The observation will be performed with naked eye under the light of dental unit and cheek will be retracted via dental mirror instrument. Method of testing: Presence of moderate to severe pain, total or incomplete loss of blood clot, bare bone in the socket, and halitosis. Decision criteria: Presence of above features at the site of tooth extraction will indicate the presence of dry socket.

  5 days

Study Arms (3)

amoxicillin

EXPERIMENTAL

single preoperative oral 500 mg dose of Amoxicillin before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos.

Drug: Amoxicillin 500 Mg

metronidazole

EXPERIMENTAL

single preoperative oral 400 mg dose of metronidazol before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos.

Drug: metronidazole 400mg

conventional group

ACTIVE COMPARATOR

conventional therapy for prevention of dry socket post operative; 400mg metrinidazol 3 times a day for 5 days 500mg of amooxicillin 2 times a day for 5 days painkiller 48 hours after extraction then sos

Drug: metronidazol 400mg and amoxicillin 500mg

Interventions

Amoxicillin 500 Mg DRUG

Amoxicillin 500mg an hour before tooth extraction

Also known as: amoxill 500mg

amoxicillin

metronidazole 400mg DRUG

400mg of metronidazole an hour before extraction

Also known as: flygel 400mg

metronidazole

metronidazol 400mg and amoxicillin 500mg DRUG

400mg metronidazole TDS, amoxicillin 500mg BD for 5 days after extraction

conventional group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requiring surgical extraction of lower third molars with class 2 impaction.
• Males and females were included.
• Age range of the patients was between 18 to 40 years.

You may not qualify if:

• Non-surgical extractions, extractions of other then lower molars,
• Infected tooth.
• tooth with grade 3 or greater mobility.
• Reluctant to participate.
• Pregnant ladies.
• Nursing mothers.
• Alcoholic patients.
• Smokers.
• Patients taking oral contraceptives.
• Patient already taking antibiotics.
• Allergic to amoxicillin and metronidazole.
• Patients on anticoagulant therapy i.e. warfarin, nicoumalone, phenytoin, fluocil.
• Those with severe renal and hepatic dysfunction.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Dry Socket

Interventions

Amoxicillin; Metronidazole; Benchmarking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate trainee

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: October 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: April 15, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

PA (1)