Trial Outcomes & Findings for Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs (NCT NCT05751382)

Results Overview

The restorations will be evaluated using the World Dental Federation (FDI) criteria.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

At 36 months follow-up.

Results posted on

2025-01-13

Participant Flow

Early termination.

Unit of analysis: Restoration type

Participant milestones

Participant milestones
Measure	Restoration With Surefil One Hybrid Composite In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.	Restoration With Venus Pearl Composite In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.
Overall Study STARTED	16 16	16 16
Overall Study COMPLETED	16 16	16 16
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restoration With Surefil One Hybrid Composite n=16 Restoration type In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL.	Restoration With Venus Pearl Composite n=16 Restoration type In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive.	Total n=32 Restoration type Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=16 Participants	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=16 Participants	15 Participants n=16 Participants	30 Participants n=16 Participants
Age, Categorical >=65 years	1 Participants n=16 Participants	1 Participants n=16 Participants	2 Participants n=16 Participants
Sex: Female, Male Female	6 Participants n=16 Participants	6 Participants n=16 Participants	12 Participants n=16 Participants
Sex: Female, Male Male	10 Participants n=16 Participants	10 Participants n=16 Participants	20 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At 36 months follow-up.

Population: Premature termination of study.

The restorations will be evaluated using the World Dental Federation (FDI) criteria.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 36 months follow-up

Population: Premature termination of study.

The restorations will be evaluated using the United States Public Health Service (USPHS) criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6, 12 and 24 months follow-up

The restorations will be evaluated using the FDI criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6, 12 and 24 months follow-up

The restorations will be evaluated using the USPHS criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6, 12, 24 and 36 months follow-up

The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6, 12, 24 and 36 months follow-up

Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

The time needed to perform the restorations will be compared between the groups.

Outcome measures

Outcome data not reported

Adverse Events

Restoration With Surefil One Hybrid Composite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Restoration With Venus Pearl Composite

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

AnnaKarin Lungren Dr.

Dentsply Sirona Implants and Consumables

Phone: 0046 702 666 492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place