Clinical, Microbiological and Quality of Life Outcomes Following Use of Systemic and Local Antimicrobials in the Management of Odontogenic Infections in Paediatric Patients
Phase: PHASE2
Conditions: Dentoalveolar Abscess
Sponsor: University of Malaya

RESEARCH PROTOCOL (DAY 1)  
 
 
 
NO 
YES 
NO 
Brief clerking & examination 
done by Receiving Postgraduate 
Postgraduate to notify SK 
SK to screen patient & take 
radiographs to assess eligibility 
to participate in study 
 
Inform parents/guardian regarding 
participation in the study 
Inclusion criteria 
-Patients presenting with acute 
odontogenic infections on 
primary teeth with evidence of 
intra-oral / extra- oral swelling 
and pus discharge 
-Absence of any systemic 
disease 
-Age group between 3-11 years 
-Very –uncooperative patients 
 
Exclusion criteria 
-Patients taking antibiotics 30 days prior 
to their attendance to the department 
-Presence of any systemic disease 
-Patients with cellulitis  
-Patients suffering from spreading 
odontogenic infections which require 
hospitalization or immediate IV 
antibiotic treatment 
-Tooth with poor prognosis for 
extraction 
-Extensively resorbed roots (> 2/3rd) 
-Patients allergic or resistance to 
amoxicillin 
SK to give PIS to parents  
To sign informed consent 
1) SK to do Brief E&D  
2) Take clinical Photographs 
3) Record clinical parameters 
 
Receiving Postgraduate continue 
management accordingly 
EMA to record Dental Charting 
& PUFA Index 
Questionnaire given to 
parents/guardian  
Exclude 
Randomization 
    SK : researcher/PG 1 
AAK : researcher/PG 2 
   EMA : researcher/PG 3 
Patient Registration 
AGREE 
DISAGREE 
BY RA 
YES 

 
 
 
SK/PG 
AAK 
SK/PG 
1) Isolation with dental dam  
 
* to be placed by PG oncall 
2) Disinfection with 30% Hydrogen Peroxide 
3) Flush with 10% Iodine Tincture 
4) Flush with 5% Thiosulphate 
5) Access cavity using Sterilized Round Bur  
6) Flush with sterilized saline 
7) Paperpoint inserted into canal (2 paperpoints to be      
    used each at 30s)  
8) Canal preparation using sterilized K-File up to size 20 
9) Flush with sterilized saline  
10) Dry canals with Paperpoints  
11) Placement of intracanal medicament using    
      sterilized lentulospiral for group 1 and 2 
12) Temporize using ZOE temporary restorative  
       material (Kalzinol) as base  
13) Seal cavity with GIC restoration (Riva capsule) 
14) Apply Vaseline over GIC 
15) Prescribe oral amoxicillin for group 3 
 
 

      DAY 3 
 
 
 
 
 
 
DAY 5,6 or 7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Handling of Sample 
 
 
SK to record clinical parameters & 
Check quality of temporary restorations 
SK to examine and 
record clinical 
parameters 
AAK to check for 
quality of temporary 
restoration 
EMA to give 
Questionnaire to 
parents/guardian 
SK/PG 
AAK 
SK/EMA/AAK 
1) Isolation with dental dam  
2) Disinfection with 30% Hydrogen Peroxide 
3) Flush with 10% Iodine Tincture 
4) Flush with 5% Thiosulphate 
5) Remove Temporary GIC using Sterilized Round Bur  
6) Flush with sterilized saline 
7) Paperpoint inserted into canal (2 paperpoints to be 
used each at 30s)  
8) Canal preparation using sterilized K-File up to size 30 
9) Flush with sterilized saline  
10) Dry canals with Paperpoints  
11) Placement of Vitapex using sterilized lentulospiral  
12) Seal cavity with GIC restoration (Riva capsule) 
13) Apply Vaseline over GIC 
14) Place patient under treatment pool 
 

Handling of sample 
 
 
Paperpoints (2) placed 
inside Eppendorf Tube 
with VMGA III 
Placed inside an Ice box 
Transfer to Lab Level 7  
Placement of sample in -80 
degree Celcius freezer