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Dentoalveolar AbscessPhase 2NCT03761264

Systemic and Local Antimicrobials in the Management of Dental Abscess in Children

A Phase 2 study testing Odontopaste®, Pulpdent and Amoxicillin in people with Dentoalveolar Abscess, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dental infections originating in the teeth are routinely managed systemically with a course of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental infections can also be managed by removing the offending cause of the infection followed by placement of an intra-canal medication which… Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Dentoalveolar Abscess
What is being tested?
Odontopaste®, Pulpdent and Amoxicillin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteMalaysia
Study dates
18 Sep 2018to 13 Feb 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
  • Malaysian citizen

Who cannot join

  • 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
  • Non-Malaysian citizen

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University of Malaya

    Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: Clinical, Microbiological and Quality of Life Outcomes Following Use of Systemic and Local Antimicrobials in the Management of Odontogenic Infections in Paediatric Patients

Dental infections originating in the teeth are routinely managed systemically with a course of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental infections can also be managed by removing the offending cause of the infection followed by placement of an intra-canal medication which acts as a local antimicrobial. Intra-canal medicaments are being used in clinical practice following root canal treatment. The investigators hypothesize that the effect of intra-canal antimicrobials in the management of dental infections will be the better than oral antibiotics in terms of clinical , microbial and oral- health quality of life parameters. This will be a three-arm, parallel, comparative, randomized study with the aim of assessing the efficacy of intra-canal medication and oral antibiotics in reducing the infection and treatment of odontogenic infections, based on signs and symptoms and microbial count. The study will be performed in child participants between the age group of 3 to 11 years presenting with acute odontogenic infections. Participants will be randomized by block randomization. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the response. Participants will be assessed on Day 3 and Day 5/7. Concurrently, the oral health-related quality of life (OHRQoL) following these clinical interventions in children will be recorded and again on Day 14. Quantitative assessment of microorganisms seen in the root canals and the changes seen in the microbial flora through the treatment will help us to determine the best antimicrobial agent to be used in the management of odontogenic infections.

Read the detailed description

This study will comprise of a three-arm, parallel, comparative, randomized treatment of children aged 3 to 11 years presenting with acute odontogenic infection. The three arms of the study includes 1) Odontopaste® as a one time intra-canal placement, 2) Calcium hydroxide (gold standard) as a one time intra-canal placement and 3) a course of amoxicillin three times daily for 5 days administered orally with meal. Patients will not receive additional medical therapy such as analgesics or anti-inflammatory drugs. The participants will be selected for the treatment based on a block randomization in groups of three. On Day 1 after confirming the eligibility based on clinical examination and radiographic finding, informed consent will be obtained. At baseline (Day 1), clinical parameters including pain,swelling, regional lymphadenitis, percussion of the tooth, trismus, fistula and pus discharge will be recorded. Participant will undergo an intervention whereby the tooth will be opened from the clinical crown followed by microbiological sampling, drainage and irrigation of the tooth, intra-canal medicament placed in the canals according to randomization and the cavity sealed with a Glass ionomer cement. Participants in the oral antibiotic group will have no intra-canal medicament placed and instead a sterile cotton pellet placed. Simultaneously, the Malay-ECOHIS will be given to the parent/guardian of the participant. The microbiological sampling will be stored in an appropriate transport medium and sent to the central laboratory for quantitative assessment via quantitative polymerase chain reaction (qPCR) using SYBR® Green. Participants will be assessed on Day 3 for clinical parameters and the integrity of restoration. The next and final assessment will be done at Day 5/7, where clinical parameters will be recorded along with microbiological sampling as in Day 1. The Malay-ECOHIS survey will be repeated. The primary objective of the study is to assess the resolution of the infection based on 1) clinical parameters, 2) microbiological sampling and 3) oral health quality of life. The treatment will be carried out by five operators who are calibrated and the individual sub components such as recording clinical parameters, microbiological sampling and assessing the OHRQoL questionnaire will be carried out by the same operator respectively.

Being tested
Odontopaste®, Pulpdent, Amoxicillin
Keywords
Odontogenic Infections, Paediatric Patients, Local Antimicrobials, Systemic Antimicrobials, Dentoalveolar Abscess, Apical Dentoalveolar Abscess, Periapical Abscess, Suppurative Periapical Periodontitis
Medical subject headings
Periapical Abscess

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Odontopaste®Drug

    Also called Zinc Oxide based endodontic dressing

    Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste® will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.

  • PulpdentDrug

    Also called Calcium hydroxide endodontic paste

    Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.

  • AmoxicillinDrug

    Also called Amoxycillin

    Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days

Study groups in NCT03761264
Study groupRoleWhat they receive
Intra-canal Odontopaste®ExperimentalSingle visit placement of Odontopaste®
Receives: Drug: Odontopaste®
Intra-canal PulpdentActive comparatorSingle visit placement of Pulpdent
Receives: Drug: Pulpdent
Oral AmoxicillinActive comparatorAmoxicillin 15mg/kg tds for 5 days
Receives: Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7

    Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews.

    Measured: Baseline, Days 3, 5 or 7

  2. Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7

    Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews.

    Measured: Baseline, Days 3, 5 or 7

  3. Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7

    Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful.

    Measured: Baseline, Days 3, 5 or 7

  4. Mean Change From Baseline in Temperature Score at Days 3, 5 or 7

    Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)

    Measured: Baseline, Days 3, 5 or 7

  5. Mean Change From Baseline in Trismus Score at Days 3, 5 or 7

    Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm).

    Measured: Baseline, Days 3, 5 or 7

  6. Mean Change From Baseline in Percussion Score at Days 3, 5 or 7

    Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness.

    Measured: Baseline, Days 3, 5 or 7

  7. Mean Change From Baseline in Fistula Score at Days 3, 5 or 7

    Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula

    Measured: Baseline, Days 3, 5 or 7

  8. Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7

    Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge.

    Measured: Baseline, Days 3, 5 or 7

  9. Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7

    Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment.

    Measured: Baseline, Day 5 or Day 7

  10. Mean change of ECOHIS scores from baseline and at Day 5 or Day 7

    Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = "I don't know". The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7.

    Measured: Baseline, Day 5 or Day 7

Secondary outcomes (1)

  1. Quantification of Individual Target Species

    A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species.

    Measured: First 2 Months of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start18 Sep 2018
  3. Primary completion13 Feb 2020
  4. Study completion13 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761264
Sponsor's protocol ID
RP053A-17HTM
Status last verified
May 2020
First submitted
29 Nov 2018
Last updated
12 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Caufield PW, Griffen AL. Dental caries. An infectious and transmissible disease. Pediatr Clin North Am. 2000 Oct;47(5):1001-19, v. doi: 10.1016/s0031-3955(05)70255-8.

    PubMed 11059347

  • Nair PN. Pathogenesis of apical periodontitis and the causes of endodontic failures. Crit Rev Oral Biol Med. 2004 Nov 1;15(6):348-81. doi: 10.1177/154411130401500604.

    PubMed 15574679

  • Robertson D, Smith AJ. The microbiology of the acute dental abscess. J Med Microbiol. 2009 Feb;58(Pt 2):155-162. doi: 10.1099/jmm.0.003517-0.

    PubMed 19141730

  • Walsh LJ. Serious complications of endodontic infections: some cautionary tales. Aust Dent J. 1997 Jun;42(3):156-9. doi: 10.1111/j.1834-7819.1997.tb00113.x.

    PubMed 9241924

  • Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.

    PubMed 8734709

  • Lewis MA. Why we must reduce dental prescription of antibiotics: European Union Antibiotic Awareness Day. Br Dent J. 2008 Nov 22;205(10):537-8. doi: 10.1038/sj.bdj.2008.984.

    PubMed 19023306

  • Dar-Odeh N, Ryalat S, Shayyab M, Abu-Hammad O. Analysis of clinical records of dental patients attending Jordan University Hospital: Documentation of drug prescriptions and local anesthetic injections. Ther Clin Risk Manag. 2008 Oct;4(5):1111-7. doi: 10.2147/tcrm.s3727.

    PubMed 19209291

  • Dar-Odeh NS, Abu-Hammad OA, Al-Omiri MK, Khraisat AS, Shehabi AA. Antibiotic prescribing practices by dentists: a review. Ther Clin Risk Manag. 2010 Jul 21;6:301-6. doi: 10.2147/tcrm.s9736.

    PubMed 20668712

  • Hills-Smith H, Schuman NJ. Antibiotic therapy in pediatric dentistry. II. Treatment of oral infection and management of systemic disease. Pediatr Dent. 1983 Mar;5(1):45-50. No abstract available.

    PubMed 6344030

  • Bansal R, Jain A. Overview on the current antibiotic containing agents used in endodontics. N Am J Med Sci. 2014 Aug;6(8):351-8. doi: 10.4103/1947-2714.139277.

    PubMed 25210667

  • Farhad A, Mohammadi Z. Calcium hydroxide: a review. Int Dent J. 2005 Oct;55(5):293-301. doi: 10.1111/j.1875-595x.2005.tb00326.x.

    PubMed 16245464

  • Rodd HD, Waterhouse PJ, Fuks AB, Fayle SA, Moffat MA; British Society of Paediatric Dentistry. Pulp therapy for primary molars. Int J Paediatr Dent. 2006 Sep;16 Suppl 1:15-23. doi: 10.1111/j.1365-263X.2006.00774.x. No abstract available.

    PubMed 16939452

  • Matijevic S, Lazic Z, Kuljic-Kapulica N, Nonkovic Z. Empirical antimicrobial therapy of acute dentoalveolar abscess. Vojnosanit Pregl. 2009 Jul;66(7):544-50. doi: 10.2298/vsp0907544m.

    PubMed 19678579

  • Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.

    PubMed 28931398

  • Siqueira JF Jr, Rocas IN, Lopes HP. Patterns of microbial colonization in primary root canal infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Feb;93(2):174-8. doi: 10.1067/moe.2002.119910.

    PubMed 11862207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Odontopaste®, Pulpdent and Amoxicillin in people with Dentoalveolar Abscess, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7 (time frame: Baseline, Days 3, 5 or 7). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761264, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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