Trial Outcomes & Findings for Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth (NCT NCT02492841)
NCT ID: NCT02492841
Last Updated: 2024-05-30
Results Overview
vitality test with electric device cold and hot test radiographic evaluation
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
169 participants
Primary outcome timeframe
3 months, 6 moths and 12 months
Results posted on
2024-05-30
Participant Flow
Participant milestones
| Measure |
Mineral Trioxide Aggregate (MTA)
Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
|
Calcium Hydroxide
-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
|
Biodentine
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
60
|
|
Overall Study
COMPLETED
|
22
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
34
|
31
|
35
|
Reasons for withdrawal
| Measure |
Mineral Trioxide Aggregate (MTA)
Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
|
Calcium Hydroxide
-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
|
Biodentine
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
34
|
31
|
35
|
Baseline Characteristics
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
Baseline characteristics by cohort
| Measure |
Mineral Trioxide Aggregate (MTA)
n=56 Participants
Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
|
Calcium Hydroxide
n=53 Participants
-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
|
Biodentine
n=60 Participants
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.51 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
11.64 years
STANDARD_DEVIATION 2.65 • n=7 Participants
|
11.22 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
11.44 years
STANDARD_DEVIATION 2.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Tooth
Maxillary First molar
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Tooth
Maxillary Second molar
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Tooth
Mandibular First molar
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Tooth
Mandibular Second molar
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 moths and 12 monthsPopulation: Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.
vitality test with electric device cold and hot test radiographic evaluation
Outcome measures
| Measure |
Mineral Trioxide Aggregate (MTA)
n=22 Participants
Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
|
Calcium Hydroxide
n=22 Participants
-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
|
Biodentine
n=25 Participants
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
|
|---|---|---|---|
|
Parameters Evaluated After Treatment
Succesfull treatment
|
19 Participants
|
19 Participants
|
25 Participants
|
|
Parameters Evaluated After Treatment
Need other treatment
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week, 3 and 6 monthsName any adverse effects caused by treatment.
Outcome measures
| Measure |
Mineral Trioxide Aggregate (MTA)
n=22 Participants
Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate
|
Calcium Hydroxide
n=22 Participants
-material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
|
Biodentine
n=25 Participants
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
|
|---|---|---|---|
|
Number of Participants With Adverse Effects
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Mineral Trioxide Aggregate (MTA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Calcium Hydroxide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biodentine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place