Trial Outcomes & Findings for RCT of Pulp Capping Over Carious Exposure in Adults (NCT NCT01224925)

Last Updated: 2019-03-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

44 month

Results posted on

2019-03-18

Participant Flow

Four Dental Clinics

Ten subjects were excluded due to a lack of pulpal exposure after the complete removal of caries before assignment to groups

Participant milestones

Participant milestones
Measure	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	WMTA - White Mineral Trioxide Aggregate Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX. After one week, the entire temporary filling was removed the cavity was permanently restored with a composite resin material used at the study clinic
Overall Study STARTED	37	33
Overall Study COMPLETED	34	31
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	WMTA - White Mineral Trioxide Aggregate Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX. After one week, the entire temporary filling was removed the cavity was permanently restored with a composite resin material used at the study clinic
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

RCT of Pulp Capping Over Carious Exposure in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dycal - Calcium Hydroxide Material n=37 Participants 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	WMTA - White Mineral Trioxide Aggregate n=33 Participants 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	Total n=70 Participants Total of all reporting groups
Age, Continuous	30.9 years STANDARD_DEVIATION 9.9 • n=5 Participants	30.2 years STANDARD_DEVIATION 9.7 • n=7 Participants	30.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex/Gender, Customized	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Tooth number Upper first molar	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants
Upper second molar	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Lower first molar	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants
Lower second molar	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Cavity type Occlusial	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Mesial-occlusial	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Distal-occlusial	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Mesial-oclusial-distal	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Caries depth 2/3 into the dentine	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Caries depth >2/3 into the dentine	8 participants n=5 Participants	15 participants n=7 Participants	23 participants n=5 Participants
Into the pulp	24 participants n=5 Participants	12 participants n=7 Participants	36 participants n=5 Participants
Preoperative pain Pain at baseline - yes	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants
Preoperative pain Pain at baseline -no	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dycal - Calcium Hydroxide Material n=37 Tooth Pulp capping with Dycal direct pulp capping over carious exposure: Dycal: covered with Fuji IX	WMTA - White Mineral Trioxide Aggregate n=33 Tooth Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX
Survival of Capped Pulps	842 Survival days Interval 693.0 to 991.0	1201 Survival days Interval 1068.0 to 1335.0

SECONDARY outcome

Timeframe: one week

Population: Postoperative pain 1 week after treatment

Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.

Outcome measures

Outcome measures
Measure	Dycal - Calcium Hydroxide Material n=37 Participants Pulp capping with Dycal direct pulp capping over carious exposure: Dycal: covered with Fuji IX	WMTA - White Mineral Trioxide Aggregate n=33 Participants Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX
Postoperative Pain 1 Week After Treatment.	8 participants	10 participants

Adverse Events

Capping Over Carious Exposure With Dycal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Capping Over Carious Exposure With WMTA

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

Associate professor Rita Kundzina

UiT The Arctic University of Norway (Tromsø university)

Phone: +4777649118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place