Carious Exposure, Human Permanent First and Second Molars, Mature Teeth, Proximal Caries, Healthy Pulp, Reversible Pulpitis
Conditions
Keywords
carious exposure, pulp capping, MTA, Dycal
Brief summary
This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.
Detailed description
Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth. A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies. Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.
Interventions
PROCEDUREDirect pulp capping with Dycal
Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling
PROCEDUREDirect pulp capping
WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.
Sponsors
Norwegian Public dental health service
University of Tromso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient -blinded
Intervention model description
Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-55 years * 1st and 2nd permanent molars * Proximal caries to inner 1/3 of dentin (bite-wing) * Apex closed, no periapical changes (apical radiograph) * No periodontal pockets deeper than 4mm * Medical history non-contributory (incl.pregnancy) * No medication (no antibiotics during last month) * No signs or symptoms more severe than reversible pulpitis * Positive response to electrical pulp test(EPT) or cold test * Written consent Inclusion requires compliance with all the criteria listed
Exclusion criteria
* During the treatment there will be no pulpal exposure * The bleeding of the exposed pulp cannot be controled in 10 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of Capped Pulps | 44 month | Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain 1 Week After Treatment. | one week | Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded. |
Countries
Lithuania, Norway
Participant flow
Recruitment details
Four Dental Clinics
Pre-assignment details
Ten subjects were excluded due to a lack of pulpal exposure after the complete removal of caries before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| Dycal - Calcium Hydroxide Material Pulp capping with Dycal
Direct pulp capping over carious exposure: Dycal: covered with Fuji IX. After one week,part of the temporary filling was left under the permanent filling | 37 |
| WMTA - White Mineral Trioxide Aggregate Pulp capping with Mineral Trioxide Aggregate
Direct pulp capping: WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic | 33 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Dycal - Calcium Hydroxide Material | Total | WMTA - White Mineral Trioxide Aggregate |
|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 9.9 | 30.6 years STANDARD_DEVIATION 9.8 | 30.2 years STANDARD_DEVIATION 9.7 |
| Caries depth >2/3 into the dentine | 8 participants | 23 participants | 15 participants |
| Caries depth 2/3 into the dentine | 5 participants | 11 participants | 6 participants |
| Cavity type Occlusial | 2 participants | 4 participants | 2 participants |
| Distal-occlusial | 11 participants | 22 participants | 11 participants |
| Into the pulp | 24 participants | 36 participants | 12 participants |
| Lower first molar | 14 participants | 19 participants | 5 participants |
| Lower second molar | 6 participants | 14 participants | 8 participants |
| Mesial-occlusial | 16 participants | 29 participants | 13 participants |
| Mesial-oclusial-distal | 8 participants | 15 participants | 7 participants |
| Preoperative pain Pain at baseline -no | 19 participants | 36 participants | 17 participants |
| Preoperative pain Pain at baseline - yes | 18 participants | 34 participants | 16 participants |
| Sex/Gender, Customized | 0 participants | 0 participants | 0 participants |
| Tooth number Upper first molar | 10 participants | 23 participants | 13 participants |
| Upper second molar | 7 participants | 14 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 33 |
| other Total, other adverse events | 0 / 37 | 0 / 33 |
| serious Total, serious adverse events | 0 / 37 | 0 / 33 |
Outcome results
Primary
Survival of Capped Pulps
Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.
Time frame: 44 month
Population: Three patients were lost from follow-up in Dycal group, two patients in WMTA group. Intention to treat principle (ITT) was applied; the analysis comprised all allocated cases
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dycal - Calcium Hydroxide Material | Survival of Capped Pulps | 842 Survival days |
| WMTA - White Mineral Trioxide Aggregate | Survival of Capped Pulps | 1201 Survival days |
Comparison: The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.p-value: <0.0195% CI: [693, 991]Log Rank
p-value: <0.0195% CI: [1068, 1335]Log Rank
Secondary
Postoperative Pain 1 Week After Treatment.
Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.
Time frame: one week
Population: Postoperative pain 1 week after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dycal - Calcium Hydroxide Material | Postoperative Pain 1 Week After Treatment. | 8 participants |
| WMTA - White Mineral Trioxide Aggregate | Postoperative Pain 1 Week After Treatment. | 10 participants |
p-value: >0.05Chi-squared