Vital Pulp TherapyPhase 4NCT02574468
Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp
A Phase 4 study testing Dexamethasone applied on pulp or Dexamethasone did not applied on pulp and DPC or MP in people with Vital Pulp Therapy, run by Isfahan University of Medical Sciences.
Trial summary
Abstract Aim The aim of this randomized clinical trial was to histologically investigate possible effects of dexamethasone application on pulp tissue healing during one step mineral trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy human premolar teeth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- Dexamethasone applied on pulp or Dexamethasone did not applied on pulp and DPC or MP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy adult patients who had four intact fully developed upper and lower premolars needed to be extracted because of his/her orthodontic treatment plan were eligible
Who cannot join
- clinical and/or radiographic caries
- restorations, periodontal problems
- intake of anti-inflammatory medication before (over the last couple of weeks) and during the study
- known allergy and/or contraindications to dexamethasone
About this study
Abstract Aim The aim of this randomized clinical trial was to histologically investigate possible effects of dexamethasone application on pulp tissue healing during one step mineral trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy human premolar teeth.
Methodology Forty intact premolar teeth of 10 orthodontic patients, scheduled for extraction, were randomized for DPC (n=20) or MP (n=20). A high speed bur under copious water coolant was used for mechanical exposing of buccal pulp horn site. Prior to sealing with white ProRoot MTA, 10 out of twenty pulpal wounds of each group were randomly received dexamethasone. Cavities were restored with glass ionomer. Teeth vitality was evaluated in 7, 21, 42, and 60 day follow-ups. Signs and/or symptoms of irreversible pulpitis or pulp necrosis were considered as failure. After 60 days, the teeth were extracted and submitted for histological examination. Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the data (P=0.05).
HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda
Read the detailed description
Clinical procedures All clinical procedures took place at private office of first author (J.G.). Using simple randomization procedures (computerized random numbers), forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, cedax, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm. All of the cavity preparation procedures were intermittently performed under copious water coolant and light hand pressure. Using a sterile 5.25% NaOCl-soaked cotton pellet, bleeding from the exposure site was controlled and 2ml of sterile saline rinsed off NaOCl residues. For blinding the practitioner to the materials, dexamethasone (Dr.abidi, Tehran, Iran) and placebo were held in identical light proof syringes and numbered for each tooth according to the randomization schedule. Each tooth was assigned an order number and its pulpal wound received the solution in the corresponding prepacked syringe prior to sealing off the exposure site with white ProRoot MTA (Dentsply, Tulsa, OK); MTA was mixed according to the manufacturer's directions and a wet cotton pellet was placed over the material for 10 minutes. Eventually, the coronal cavity was restored with light cure resin modified glass ionomer (Fuji II LC; GC Corporation, Tokyo, Japan) and cured for 40 seconds using a curing light. All clinical procedures were performed by the same practitioner (J.G.). All patients took 400 mg of ibuprofen (as a single dose) for postoperative pain control. Pulp and periapical status were clinically (7, 21, 42, and 60 days) and radiographically evaluated (42, and 60 days) during the study. Clinical and radiographic signs and/or symptoms of irreversible pulpitis or pulp necrosis were considered as treatment failure. On the 60th day teeth were extracted atraumatically and prepared for submission to the oral pathology department for processing.
- Conditions
- Vital Pulp Therapy
- Being tested
- Dexamethasone applied on pulp or Dexamethasone did not applied on pulp, DPC or MP
- Keywords
- Dexamethasone, Direct pulp capping, MTA, pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone applied on pulp or Dexamethasone did not applied on pulpDrug
on half of cases we put dexamethasone on pulp on other half we did not put dexamethasone on pulp
DPC or MPProcedure or surgery
on half of cases we treat teeth with DPC(Direct Pulp Cap) on other half we treat teeth with MP(Miniature Pulpotomy)
| Study group | Role | What they receive |
|---|---|---|
| DPC+Dexa | Active comparator | forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm Receives: Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp; Procedure: DPC or MP |
| MP+Dexa | Active comparator | forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm Receives: Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp; Procedure: DPC or MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Evaluation of pulp for inflammation
measure number of inflammatory cells for amount of inflammation
Measured: one year
Histologic Evaluation of pulp for calcified bridge
measure thickness of calcified bridge on the pulp
Measured: one year
Histologic Evaluation of pulp for odontoblast layer
measure odontoblastic cells on odontoblast layer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Responsible party
- Principal investigator, Seyed Amir Mousavi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574468
- Sponsor's protocol ID
- 91_509
- Status last verified
- Oct 2015
- First submitted
- 3 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp
- ClinicalTrials.gov ID
- NCT02574468
- Acronym / sponsor ID
- 91_509
- Conditions
- Vital Pulp Therapy
- Keywords
- Dexamethasone, Direct pulp capping, MTA, pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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.
Abstract Aim The aim of this randomized clinical trial was to histologically investigate possible effects of dexamethasone application on pulp tissue healing during one step mineral trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy human premolar teeth.
Methodology Forty intact premolar teeth of 10 orthodontic patients, scheduled for extraction, were randomized for DPC (n=20) or MP (n=20). A high speed bur under copious water coolant was used for mechanical exposing of buccal pulp horn site. Prior to sealing with white ProRoot MTA, 10 out of twenty pulpal wounds of each group were randomly received dexamethasone. Cavities were restored with glass ionomer. Teeth vitality was evaluated in 7, 21, 42, and 60 day follow-ups. Signs and/or symptoms of irreversible pulpitis or pulp necrosis were considered as failure. After 60 days, the teeth were extracted and submitted for histological examination. Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the data (P=0.05).
HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda
Detailed description
Clinical procedures All clinical procedures took place at private office of first author (J.G.). Using simple randomization procedures (computerized random numbers), forty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, cedax, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm. All of the cavity preparation procedures were intermittently performed under copious water coolant and light hand pressure. Using a sterile 5.25% NaOCl-soaked cotton pellet, bleeding from the exposure site was controlled and 2ml of sterile saline rinsed off NaOCl residues. For blinding the practitioner to the materials, dexamethasone (Dr.abidi, Tehran, Iran) and placebo were held in identical light proof syringes and numbered for each tooth according to the randomization schedule. Each tooth was assigned an order number and its pulpal wound received the solution in the corresponding prepacked syringe prior to sealing off the exposure site with white ProRoot MTA (Dentsply, Tulsa, OK); MTA was mixed according to the manufacturer's directions and a wet cotton pellet was placed over the material for 10 minutes. Eventually, the coronal cavity was restored with light cure resin modified glass ionomer (Fuji II LC; GC Corporation, Tokyo, Japan) and cured for 40 seconds using a curing light. All clinical procedures were performed by the same practitioner (J.G.). All patients took 400 mg of ibuprofen (as a single dose) for postoperative pain control. Pulp and periapical status were clinically (7, 21, 42, and 60 days) and radiographically evaluated (42, and 60 days) during the study. Clinical and radiographic signs and/or symptoms of irreversible pulpitis or pulp necrosis were considered as treatment failure. On the 60th day teeth were extracted atraumatically and prepared for submission to the oral pathology department for processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPC+Dexa | Active comparator | Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp, Procedure: DPC or MPforty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm |
| MP+Dexa | Active comparator | Drug: Dexamethasone applied on pulp or Dexamethasone did not applied on pulp, Procedure: DPC or MPforty intact premolars were randomly assigned to 1 of 4 treatment groups (n=10): I) DPC, II) MP, III) DPC+dexamethasone, and IV) MP+dexamethasone. After administration of local anesthesia (3% mepivacaine plain; Septodont, Cedex, France) dental rubber dam was applied and tooth surface disinfected with 2% chlorhexidine gluconate. Occlusal cavity was prepared using high speed diamond fissure bur and buccal pulp horn was mechanically exposed (approximately 1.2 mm in diameter) using a sterile high speed carbide round bur. In MP, depth of penetration to the pulp was 0.5 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult patients who had four intact fully developed upper and lower premolars needed to be extracted because of his/her orthodontic treatment plan were eligible
Key exclusion criteria (4 listed)
- clinical and/or radiographic caries
- restorations, periodontal problems
- intake of anti-inflammatory medication before (over the last couple of weeks) and during the study
- known allergy and/or contraindications to dexamethasone
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 |
|---|---|---|
| Dexamethasone applied on pulp or Dexamethasone did not applied on pulpon half of cases we put dexamethasone on pulp on other half we did not put dexamethasone on pulp | Drug | DPC+Dexa, MP+Dexa |
| DPC or MPon half of cases we treat teeth with DPC(Direct Pulp Cap) on other half we treat teeth with MP(Miniature Pulpotomy) | Procedure or surgery | DPC+Dexa, MP+Dexa |
Primary outcome
Histologic Evaluation of pulp for inflammation
Time frame: one year
measure number of inflammatory cells for amount of inflammation
Histologic Evaluation of pulp for calcified bridge
Time frame: one year
measure thickness of calcified bridge on the pulp
Histologic Evaluation of pulp for odontoblast layer
Time frame: one year
measure odontoblastic cells on odontoblast layer
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 14 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone applied on pulp or Dexamethasone did not applied on pulp and DPC or MP in people with Vital Pulp Therapy, run by Isfahan University of Medical Sciences.
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 1 inclusion and 4 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 14 Oct 2015. 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 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?
Histologic Evaluation of pulp for inflammation (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.