Focal Infection, DentalPhase 4NCT04057014

Immediate Versus Delayed Treatment of Odontogenic Infections

A Phase 4 study testing Amoxicillin and Tooth extraction in people with Focal Infection, Dental, run by Boston Children's Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The objective of this study is to compare the physiologic resolution of dental infections between immediate tooth extraction (control group) and administration of systemic antibiotics and delayed extraction (study groups 1 and 2). Read more about this study

Who is it for?: Ages 2 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Focal Infection, Dental
What is being tested?: Amoxicillin and Tooth extraction
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Oct 2020to 2 Oct 2020
Phase: Phase 4
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 2 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Patients who present to the dental clinic or Boston Children's Hospital emergency room
Odontogenic origin associated with a primary tooth and limited to the buccal vestibule only
Ages of 2-11 years old
Primary Caregiver present
English speaking
American Society of Anesthesiologists (ASA) classification of I

Show all 9Show fewer

None or current systemic antibiotic therapy regimen < 24 hours
Able to take medication orally
Those patients who choose to participate in the study

Who cannot join

Infection that has spread beyond the buccal vestibule, or not detectable
Infection is associated with a permanent adult tooth
Ages of <2 years old or >11 years old
American Society of Anesthesiologists classification of II or greater or poor general health.
Renal impairment
Immunosuppressive disease

Show all 10Show fewer

Recent antibiotic therapy in the last 1 to 30 days
Allergy to penicillin
Unable to take oral medications
Decline participation

About this study

Official title: A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections

Read the detailed description

This is a prospective partially randomized clinical trial. Patients 2-11 years old who have a vestibular swelling associated with an odontogenic infection are being studied. Subjects will self-select into the control or study group. All subjects will be offered to have the tooth extracted on the day of diagnosis, and if this treatment is chosen they will join the control group (group 1). Subjects who defer treatment will be placed on amoxicillin and will be placed into the study group. The study group will be randomized into two parallel study groups that either have average dose antibiotics for 10 days (group 2), or maximum dose antibiotics for 5 days (group 3).

Conditions: Focal Infection, Dental
Being tested: Amoxicillin, Tooth extraction
Keywords: Dentistry, Antibiotic, Penicillin, pediatrics
Medical subject headings: Focal Infection, Dental

What participants receive

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

AmoxicillinDrug
Also called Amoxil
Antibiotic given at different dosages and durations.
Tooth extractionProcedure or surgery
Also called Exodontia
Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.

Study groups in NCT04057014
Study group	Role	What they receive
Extraction Only	Active comparator	Immediate extraction of infected tooth without antibiotic prescription. Receives: Procedure: Tooth extraction
Average Dose Antibiotic	Experimental	Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group) Receives: Drug: Amoxicillin; Procedure: Tooth extraction
High Dose Antibiotic	Experimental	High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients) Receives: Drug: Amoxicillin; Procedure: Tooth extraction

What is being measured

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

Change in diagnosis
Tooth infection not clinically detectable
Measured: Infection will be monitored at days 0, 5, 10 and 20.

Secondary outcomes (1)

Measure of pediatric oral health-related quality of life: the POQL
Quality of life compared between arms. Pediatric Oral Health Quality of Life (PQOL) clustered into four dimensions - Physical Functioning, Role Functioning, Social Functioning and Emotional Functioning. It was designed to be used in high risk, low resource, populations with greater health disparities. Specifically we are looking significant difference between the study groups that is at least 2 standard errors from the control group. If there are not two deviations to discriminate between scales would indicate a non-significant finding.
Measured: Survey of quality of life at days 0, 5, 10 and 20.

Timeline

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

Oct 20202 Oct 2020

First posted14 Aug 2019
Study startOct 2020 (estimated)
Primary completion2 Oct 2020
Study completion2 Oct 2020

Why it stopped: No funding available for the activity

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Focal Infection, DentalStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective partially randomized parallel study groups clinical trial investigation.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04057014
Sponsor's protocol ID: P00030880
Status last verified: Oct 2020
First submitted: 12 Aug 2019
Last updated: 6 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: There is no plan to share participant data.

Publications

Dodson TB, Perrott DH, Kaban LB. Pediatric maxillofacial infections: a retrospective study of 113 patients. J Oral Maxillofac Surg. 1989 Apr;47(4):327-30. doi: 10.1016/0278-2391(89)90331-5.
PubMed 2926541
Biederman GR, Dodson TB. Epidemiologic review of facial infections in hospitalized pediatric patients. J Oral Maxillofac Surg. 1994 Oct;52(10):1042-5. doi: 10.1016/0278-2391(94)90172-4.
PubMed 8089789
Rush DE, Abdel-Haq N, Zhu JF, Aamar B, Malian M. Clindamycin versus Unasyn in the treatment of facial cellulitis of odontogenic origin in children. Clin Pediatr (Phila). 2007 Mar;46(2):154-9. doi: 10.1177/0009922806289431.
PubMed 17325089
Warnke PH, Becker ST, Springer IN, Haerle F, Ullmann U, Russo PA, Wiltfang J, Fickenscher H, Schubert S. Penicillin compared with other advanced broad spectrum antibiotics regarding antibacterial activity against oral pathogens isolated from odontogenic abscesses. J Craniomaxillofac Surg. 2008 Dec;36(8):462-7. doi: 10.1016/j.jcms.2008.07.001. Epub 2008 Aug 29.
PubMed 18760616
Kara A, Ozsurekci Y, Tekcicek M, Karadag Oncel E, Cengiz AB, Karahan S, Ceyhan M, Celik MO, Ozkaya-Parlakay A. Length of hospital stay and management of facial cellulitis of odontogenic origin in children. Pediatr Dent. 2014 Jan-Feb;36(1):18E-22E.
PubMed 24717702
Lin YT, Lu PW. Retrospective study of pediatric facial cellulitis of odontogenic origin. Pediatr Infect Dis J. 2006 Apr;25(4):339-42. doi: 10.1097/01.inf.0000216202.59529.3d.
PubMed 16567986
Huntington NL, Spetter D, Jones JA, Rich SE, Garcia RI, Spiro A 3rd. Development and validation of a measure of pediatric oral health-related quality of life: the POQL. J Public Health Dent. 2011 Summer;71(3):185-93.
PubMed 21972458
Thikkurissy S, Rawlins JT, Kumar A, Evans E, Casamassimo PS. Rapid treatment reduces hospitalization for pediatric patients with odontogenic-based cellulitis. Am J Emerg Med. 2010 Jul;28(6):668-72. doi: 10.1016/j.ajem.2009.02.028. Epub 2010 Apr 2.
PubMed 20637381

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections
ClinicalTrials.gov ID: NCT04057014
Acronym / sponsor ID: P00030880
Conditions: Focal Infection, Dental
Keywords: Dentistry, Antibiotic, Penicillin, pediatrics
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No funding available for the activity
Enrolment: 0 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Study start: Oct 2020 (estimated)
Primary completion: 2 Oct 2020 (actual)
Study completion: 2 Oct 2020 (actual)
First posted: 14 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Prospective partially randomized parallel study groups clinical trial investigation.

Arm	Type	Receives
Extraction Only	Active comparator	Procedure: Tooth extractionImmediate extraction of infected tooth without antibiotic prescription.
Average Dose Antibiotic	Experimental	Drug: Amoxicillin, Procedure: Tooth extractionAverage dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group)
High Dose Antibiotic	Experimental	Drug: Amoxicillin, Procedure: Tooth extractionHigh dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients)

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (9 listed)

Patients who present to the dental clinic or Boston Children's Hospital emergency room
Odontogenic origin associated with a primary tooth and limited to the buccal vestibule only
Ages of 2-11 years old
Primary Caregiver present
English speaking

Key exclusion criteria (10 listed)

Infection that has spread beyond the buccal vestibule, or not detectable
Infection is associated with a permanent adult tooth
Ages of <2 years old or >11 years old
American Society of Anesthesiologists classification of II or greater or poor general health.
Renal impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AmoxicillinAlso: AmoxilAntibiotic given at different dosages and durations.	Drug	Average Dose Antibiotic, High Dose Antibiotic
Tooth extractionAlso: ExodontiaRemoval of infected tooth on first day of study, this approach does not require an antibiotic drug.	Procedure or surgery	Average Dose Antibiotic, Extraction Only, High Dose Antibiotic

Primary outcome

Change in diagnosis
Time frame: Infection will be monitored at days 0, 5, 10 and 20.
Tooth infection not clinically detectable

1 secondary outcome

Measure of pediatric oral health-related quality of life: the POQL
Time frame: Survey of quality of life at days 0, 5, 10 and 20.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Background: PubMed 2926541Dodson TB, Perrott DH, Kaban LB. Pediatric maxillofacial infections: a retrospective study of 113 patients. J Oral Maxillofac Surg. 1989 Apr;47(4):327-30. doi: 10.1016/0278-2391(89)90331-5.
Background: PubMed 8089789Biederman GR, Dodson TB. Epidemiologic review of facial infections in hospitalized pediatric patients. J Oral Maxillofac Surg. 1994 Oct;52(10):1042-5. doi: 10.1016/0278-2391(94)90172-4.
Background: PubMed 17325089Rush DE, Abdel-Haq N, Zhu JF, Aamar B, Malian M. Clindamycin versus Unasyn in the treatment of facial cellulitis of odontogenic origin in children. Clin Pediatr (Phila). 2007 Mar;46(2):154-9. doi: 10.1177/0009922806289431.
Background: PubMed 18760616Warnke PH, Becker ST, Springer IN, Haerle F, Ullmann U, Russo PA, Wiltfang J, Fickenscher H, Schubert S. Penicillin compared with other advanced broad spectrum antibiotics regarding antibacterial activity against oral pathogens isolated from odontogenic abscesses. J Craniomaxillofac Surg. 2008 Dec;36(8):462-7. doi: 10.1016/j.jcms.2008.07.001. Epub 2008 Aug 29.
Background: PubMed 24717702Kara A, Ozsurekci Y, Tekcicek M, Karadag Oncel E, Cengiz AB, Karahan S, Ceyhan M, Celik MO, Ozkaya-Parlakay A. Length of hospital stay and management of facial cellulitis of odontogenic origin in children. Pediatr Dent. 2014 Jan-Feb;36(1):18E-22E.
Background: PubMed 16567986Lin YT, Lu PW. Retrospective study of pediatric facial cellulitis of odontogenic origin. Pediatr Infect Dis J. 2006 Apr;25(4):339-42. doi: 10.1097/01.inf.0000216202.59529.3d.
Background: PubMed 21972458Huntington NL, Spetter D, Jones JA, Rich SE, Garcia RI, Spiro A 3rd. Development and validation of a measure of pediatric oral health-related quality of life: the POQL. J Public Health Dent. 2011 Summer;71(3):185-93.
Background: PubMed 20637381Thikkurissy S, Rawlins JT, Kumar A, Evans E, Casamassimo PS. Rapid treatment reduces hospitalization for pediatric patients with odontogenic-based cellulitis. Am J Emerg Med. 2010 Jul;28(6):668-72. doi: 10.1016/j.ajem.2009.02.028. Epub 2010 Apr 2.
Individual participant dataSharing planned: No. There is no plan to share participant data.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keri Discepolo, DDS principal investigator

Boston Children's Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amoxicillin and Tooth extraction in people with Focal Infection, Dental, run by Boston Children's Hospital.

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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change in diagnosis (time frame: Infection will be monitored at days 0, 5, 10 and 20.). 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 NCT04057014, which also lists 8 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 6 Oct 2020.