Clinical evaluation of the performance of a composite material used in the warmingtechnique

Phase 4

• Conditions: K02.9; Dental caries, unspecified

• Registration Number: DRKS00020546
• Lead Sponsor: 3M Oral Care

Brief Summary

Forty-seven of the 50 subjects were evaluated for the 36-month follow-up visit, which presents a current dropout rate of six percent. One subject moved abroad and could not attend the 36-month follow-up, consequently being considered a dropout. One subject should have shown up at scheduled recall appointments. After repeated attempts to contact the subject, he was considered a dropout. One subject withdrew from the study due to medical reasons. Three restorations received a score of 4 and were considered failing. The total survival rate was 96.8% after three years, with no significant difference between the test and control groups. The majority of the evaluated parameters' scores were either 1 or 2, meaning they were clinically excellent. For the test and control groups, there was a significant difference between baseline and 36-month scores for the following parameters: surface luster, surface staining, marginal staining, color match and translucency, marginal adaptation, approximal anatomical form – contour, tooth integrity, periodontal response, and adjacent mucosa. Surface luster: The p-value for surface luster compared to baseline in both groups was <0;0001. At baseline, 72 restorations received a score of 1. At 24 months, only 18 still had a score of 1. At 12 months, that number was 25, indicating a further decrease in surface luster each year. After three years, only two restorations were considered clinically excellent, with a score of 1. These findings are in accordance with other clinical studies and may also be attributed to another evaluator scoring the restorations after baseline evaluation. Surface staining: Surface staining was significant when comparing the scores for both groups at baseline and 36 months. The p-value for the test and control groups was <0,0001. Data shows that with each year of follow-up, the number of restorations with surface staining increases. At six months, seven restorations had a score of 2, but after three years, they were 44. Marginal staining: Marginal staining was significant when comparing the scores for both groups at baseline and 36 months, with a p-value of <0,0001. At six months, 75 restorations had a score of 1. At 36 months, the number of restorations scoring 1 had dropped to 42. All restorations either scored 1 or 2 for marginal staining. Color match and translucency: The p-value for color match was <0,0001 for both groups. The most notable difference was that no restorations scored 3 at baseline, however at 36 months 31 subjects had a score of 3, just like in the previous follow up visits. Marginal adaptation: The p-value for marginal adaptation compared to baseline in both groups was <0,0001. With slight ditching or minor irregularities occurring in 64 restorations. Tooth integrity: There was a significant difference between baseline and 36 months for both test and control groups where the p value was <0,0001 for both groups. Periodontal response: For both groups the p value was <0,0001 for periodontal response. A significant difference has been observed, but at 6- and 12-months follow-up a different reference tooth was used for some subjects by mistake. For 36 and 24 months the reference tooth was the same as the one at baseline for all subjects. Adjacent mucosa: The p value for adjacent mucosa was <0,0001 for both groups. At baseline all restorations except one had score of 1 but by the time of 24 months follow up the 59 restorations had a score of 2. Three restorations were considered a failure according to the FDI criteria. The total survival rate after three years was, therefore, 96.8% A significant difference between FDI scores at 36 months versus baseline was observed in both groups for categories surface luster, surface staining, marginal staining, color match and translucency, marginal adaptation, approximal anatomical form–contour, tooth integrity, periodontal response, and adjacent mucosa. Two adverse events occurred. One subject was diagnosed with Lichen planus and was consequently referred to an oral pathologist, and another subject had caries in a study tooth. However, the caries lesion was unrelated to the study restoration, i.e., on another tooth surface. There is no statistical difference between the study groups for FDI criteria 11: Postoperative (hyper-) sensitivity and tooth vitality, highlighting the safety of the warming technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subject is between 18 and 75 years of age

2. Subject is in good general health (ASA 1 or 2)

3. Subject does not have known allergies against any study substances

4. Subject has at least two teeth in need of a Class II restoration

5. Existing restorations that only require repair (instead of replacement) will be excluded

6. Both study teeth must have a good prognosis for the next 3 years (no increased tooth mobility,
periodontal probing depth is =5 mm, no signs of pulpitis, no pulp exposure during treatment, study
teeth are vital, level of oral hygiene is sufficient)

7. Subject does not suffer from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion

8. Each study restoration has at least one proximal contact and is stress bearing with at least one
occlusal antagonistic contact

9. In case study restorations are in antagonistic contact with each other: each study restoration has at least one antagonistic occlusal contact to natural tooth substance

10. Subject does not have excessive dietary or environmental exposure to acids or suffer from eating disorders

11. Subject is not pregnant or breast feeding

12. Subject volunteers to participate in the study and is available for recalls during the 3 years study
duration

13. Subject does not participate in any other study

Exclusion Criteria

See inclusion criteria

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Restoration survival based on FDI criteria during 3 years follow-up

Secondary Outcome Measures

Name	Time	Method
Restoration quality based on FDI criteria during 3 years follow-up