Infected Immature Permanent TeethPhase 2NCT03327844

Regenerative Endodontic Therapy (RET) for the Management of Immature Non-vital Permanent Teeth in Children

A Phase 2 study testing RET using antibiotics (Ciprofloxacin and Metronidazole) and RET using non-setting Calcium Hydroxide in people with Infected Immature Permanent Teeth, run by National University Health System, Singapore at 2 sites in Singapore.

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

This study evaluates the efficacy of Antibiotic pastes or Calcium hydroxide disinfection on healing of periapical pathology and continued root development of infected non-vital immature permanent teeth in children. Read more about this study

Who is it for?: Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Infected Immature Permanent Teeth
What is being tested?: RET using antibiotics (Ciprofloxacin and Metronidazole) and RET using non-setting Calcium Hydroxide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesSingapore
Study dates: 1 Mar 2017to 31 Jul 2021
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 6 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Patients aged 6-16 years of age
Patients who are fit and healthy or with American Society of Anesthesiologists (ASA) 1 or ASA 2 medical conditions
Patients with cooperation level that would allow treatment under local analgesia, application of rubber dam isolation and taking of intraoral radiographs.
Patients with permanent premolars that have incomplete root formation with an open apex of greater than 1mm width as observed radiographically and of single root canal morphology (22)
Patients with single rooted immature permanent premolars having one of the following pulpal and periapical diagnosis:
Pulpal i. Necrotic pulp ii. Symptomatic and inflamed pulp not expected to heal. During attempted Cvek or cervical pulpotomy procedures, if the pulpal bleeding does not stop with direct pressure within 5 minutes, pulpectomy will be carried out and the patient will be recruited for RET procedures.
Periapical i. Symptomatic apical periodontitis (with or without a radiographic apical lesion) ii. Asymptomatic apical periodontitis (with a radiographic apical lesion) iii. Acute apical abscess iv. Chronic apical abscess Teeth will be deemed non-vital if either are non-responsive to sensibility tests (i.e. Electric Pulp test and cold tests), and/or present with signs and symptoms of non-vitality (e.g. swelling and abscess).

Who cannot join

Patients aged > 16 years of age.
Patient with known allergies to Ciprofloxacin (or any fluoroquinolones class of antibiotics) or metronidazole antibiotics.
Patients with medical conditions and/or receiving medications that would affect:
Their body's ability to heal e.g. Diabetes; or
Their ability to clot efficiently, e.g. Haemophilia
Patients with risk of developing infective endocarditis or immune compromised patients.

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Patients with non-vital permanent premolars where root development is already deemed to be completed (i.e. foramen size of 0-1.0mm diameter as determined radiographically).
Impacted or horizontally tilted teeth.
Concurrent signs of irreversible pathological root resorption determined radiographically, e.g replacement or internal root resorption, which could otherwise affect the prognosis of the tooth.
Uncooperative patients, or those unable to cope with treatment under local anaesthesia, rubber dam isolation and taking of intraoral radiographs.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

School Dental Service, Health Promotion Board
Singapore, 168937
National University Hospital
Singapore

Other trials in Singapore

About this study

Official title: Regenerative Endodontic Therapy (RET) Using Antibiotic Pastes or Calcium Hydroxide Disinfection for the Management of Immature Non-vital Permanent Teeth in Children: A Randomized Controlled Clinical Trial

In the test group regenerative endodontic therapy (RET) is performed with antibiotics as the disinfecting agent, in the control group RET is performed with Calcium Hydroxide as the disinfecting agent.

Conditions: Infected Immature Permanent Teeth
Being tested: RET using antibiotics (Ciprofloxacin and Metronidazole), RET using non-setting Calcium Hydroxide
Keywords: Regenerative Endodontic Therapy, Infected immature permanent teeth

What participants receive

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

RET using antibiotics (Ciprofloxacin and Metronidazole)Drug
Also called Bi-Antibiotics
RET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.
RET using non-setting Calcium HydroxideDrug
Also called Calcium hydroxide
First Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.

Study groups in NCT03327844
Study group	Role	What they receive
RET using bi-Antibiotics	Active comparator	Interventions: Bi-antibiotics (Ciprofloxacin and Metronidazole) placed into the root canal during first treatment stage (disinfection stage) Receives: Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)
RET using non-setting Calcium Hydroxide	Active comparator	Interventions: non-setting calcium hydroxide placed into the root canal during first treatment stage (disinfection stage) Receives: Drug: RET using non-setting Calcium Hydroxide

What is being measured

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

Resolution periapical radiolucency (Clinical evaluation)
Clinical evaluation: Presence/Absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.)
Measured: 18 months (reviews are at periodicity of 3 months)
Resolution periapical radiolucency (Radiographic evaluation)
Size of periapical lesion will be graded using Periapical Index (PAI)
Measured: 18 months (reviews are at periodicity of 3 months)

Secondary outcomes (4)

Continued root development (Radiographic evaluation)
Quantitative outcomes of lengths and thickness will be measured in millimeters (mm).
Measured: 18 months (reviews are at periodicity of 3 months)
Discolouration of tooth
Changes in tooth colour will be measured through assessment of photographs
Measured: 18 months (reviews are at periodicity of 3 months)
Patient reported outcomes (Perceived oral health-related quality of life (OHRQL))
Oral health related quality of life will be evaluated using the validated questionnaire Child-Oral Impacts on daily performances (C-OIDP)
Measured: 18 months (reviews are at periodicity of 3 months)
Patient reported outcomes (Quantitative pain rating)
Quantitative pain rating will be done using Faces Pain scale for children 12 years and below; and Numeric Rating scale (NRS) for children 13 years and above.
Faces Pain Scale (range: 0-10); higher scores indicate worse pain
Numeric Rating scale (range: 0-10; 0 - no pain, 1-3 - mild pain, 4-6 - moderate pain, 7-10 - severe pain); higher scores indicate worse pain
Measured: 18 months (reviews are at periodicity of 3 months)

Timeline

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

1 Mar 201731 Jul 2021

First posted1 Nov 2017
Study start1 Mar 2017
Primary completion31 Jul 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infected Immature Permanent TeethStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03327844
Sponsor's protocol ID: DSRB 2015/00612
Status last verified: Oct 2021
First submitted: 5 Oct 2017
Last updated: 21 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Regenerative Endodontic Therapy (RET) Using Antibiotic Pastes or Calcium Hydroxide Disinfection for the Management of Immature Non-vital Permanent Teeth in Children: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03327844
Acronym / sponsor ID: DSRB 2015/00612
Conditions: Infected Immature Permanent Teeth
Keywords: Regenerative Endodontic Therapy, Infected immature permanent teeth
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: National University Health System, SingaporeUniversity, hospital or other
Collaborators: National University of Singapore, Health Promotion Board, Singapore
Study start: 1 Mar 2017 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 1 Nov 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RET using bi-Antibiotics	Active comparator	Drug: RET using antibiotics (Ciprofloxacin and Metronidazole)Interventions: Bi-antibiotics (Ciprofloxacin and Metronidazole) placed into the root canal during first treatment stage (disinfection stage)
RET using non-setting Calcium Hydroxide	Active comparator	Drug: RET using non-setting Calcium HydroxideInterventions: non-setting calcium hydroxide placed into the root canal during first treatment stage (disinfection stage)

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Patients aged 6-16 years of age
Patients who are fit and healthy or with American Society of Anesthesiologists (ASA) 1 or ASA 2 medical conditions
Patients with cooperation level that would allow treatment under local analgesia, application of rubber dam isolation and taking of intraoral radiographs.
Patients with permanent premolars that have incomplete root formation with an open apex of greater than 1mm width as observed radiographically and of single root canal morphology (22)
Patients with single rooted immature permanent premolars having one of the following pulpal and periapical diagnosis:

Key exclusion criteria (10 listed)

Patients aged > 16 years of age.
Patient with known allergies to Ciprofloxacin (or any fluoroquinolones class of antibiotics) or metronidazole antibiotics.
Patients with medical conditions and/or receiving medications that would affect:
Patients with risk of developing infective endocarditis or immune compromised patients.
Patients with non-vital permanent premolars where root development is already deemed to be completed (i.e. foramen size of 0-1.0mm diameter as determined radiographically).

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
RET using antibiotics (Ciprofloxacin and Metronidazole)Also: Bi-AntibioticsRET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.	Drug	RET using bi-Antibiotics
RET using non-setting Calcium HydroxideAlso: Calcium hydroxideFirst Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.	Drug	RET using non-setting Calcium Hydroxide

Primary outcome

Resolution periapical radiolucency (Clinical evaluation)
Time frame: 18 months (reviews are at periodicity of 3 months)
Clinical evaluation: Presence/Absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.)
Resolution periapical radiolucency (Radiographic evaluation)
Time frame: 18 months (reviews are at periodicity of 3 months)
Size of periapical lesion will be graded using Periapical Index (PAI)

4 secondary outcomes

Continued root development (Radiographic evaluation)
Time frame: 18 months (reviews are at periodicity of 3 months)
Discolouration of tooth
Time frame: 18 months (reviews are at periodicity of 3 months)
Patient reported outcomes (Perceived oral health-related quality of life (OHRQL))
Time frame: 18 months (reviews are at periodicity of 3 months)
Patient reported outcomes (Quantitative pain rating)
Time frame: 18 months (reviews are at periodicity of 3 months)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Individual participant dataSharing planned: No

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.

Huei Jinn Tong principal investigator

National University Health System

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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?

Resolution periapical radiolucency (Clinical evaluation) (time frame: 18 months (reviews are at periodicity of 3 months)). The study lists 2 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 NCT03327844.

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 21 Oct 2021.