2.1 Study participants
This study included 40 patients with 54 full-crown prostheses seen at the Department of Prosthodontics, Peking University School and Hospital of Stomatology, China, between August and December 2021. We included patients aged ≥ 18 years with at least one full-crown restoration in the anterior or posterior tooth, no systemic disease or active periodontitis, full behavioral autonomy, the ability to express themselves, and good compliance. Patients were excluded if they had poor oral hygiene, acute or chronic disease in teeth adjacent to the full-crown restoration, orthodontic bracket attachments on the tooth surface, or other characteristics that may affect photography of fixed restorations.
All subjects provided written consent prior to participation. The study was performed in accordance with the Declaration of Helsinki and approved by the Biomedical Ethics Committee of Peking University Hospital of Stomatology, Beijing, China (No.: PKUSSIRB-202165097).
2.2 Sample size
Based on the experimental design, PASS 15 software (NCSS, LLC, Kaysville, UT, USA) was used to calculate the sample size with α = 0.05 and 80% statistical power. The calculations showed a required sample size of at least 40 full-crown restorations. All patients in the randomized trial were invited to participate in the study; given that individual patients may have more than one restoration, 54 full-crown restorations were included in the study.
2.3 Black and white calibration sheet
As a black and white calibration sheet, a 1.5-mm-diameter semicircle, which was half black (R:0, G:0, B:0) and half white (R:255, G:255, B:255), was printed on a piece of self-adhesive paper and calibrated (Fig. 1). A photograph of this card, along with one of a standard black and white card, was imported into Adobe Photoshop CC 2018 (Adobe Inc., Mountain View, CA, USA) to ensure that the black and white calibration sheet was consistent with the standard color card.
2.4 Examiners and calibration
To ensure reliability of the clinical examinations (the reference standard), prosthodontist expert was trained in the use of the index to assess the marginal status of full-crown restorations according to the FDI World Dental Federation [27] criteria, and periodontal expert was trained in the use of the index to assess the gingival status of full-crown restorations according to the Modified Gingival Index(MGI)[28].The prosthodontic and periodontal specialists who performed the clinical examinations were experts with more than 10 years of experience.
To ensure accurate evaluation of the full-crown restorations based on photographs obtained using an intraoral camera (Zhimei YF200B; Baden Co., Ltd., Beijing, China), three evaluators were trained. During training, the three evaluators assessed photographs similar to those evaluated in the actual study, to ensure that they understood the evaluation methods and criteria. The study photographs were assessed once the total agreement score for the three evaluators was ≥ 85%[27, 29]. The evaluators were general dentists with less than 3 years of clinical experience.
Table 1
Marginal adaptation levels in the FDI [27]and MGI[28] levels
|
Marginal adaptation
|
|
MGI
|
1
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Harmonious outline, no gaps, no white or discolored lines.
|
0
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absence of inflammation.
|
2
|
Marginal gap (< 150 µm), white Lines; Small marginal fracture removable by polishing; Slight ditching, slight step/flashes, minor irregularities.
|
1
|
mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary.
|
3
|
Slight ditching, slight step/flashes, minor irregularities; Gap < 250 µm not removable; Several small marginal fractures; major irregularities, ditching or flash, steps.
|
2
|
mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary.
|
4
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Gap > 250 µm or dentine/base exposed; Severe ditching or marginal fractures; Larger irregularities or steps (repair necessary).
|
3
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moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary.
|
5
|
Restoration (complete or partial) is loose but in situ; Generalized major gaps or irregularities.
|
4
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severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.
|
2.5 Clinical examinations
The clinical examinations were performed by trained senior clinicians (a prosthodontist expert and a periodontal expert) with more than 10 years of clinical experience. The examinations were performed on the same day, using the same dental equipment and light conditions. The instruments used for the examinations included disposable mouth mirrors and triple syringes. Prior to the examination, the teeth were cleaned with sterile gauze to remove food deposits. Teeth were examined in a wet state, but excess saliva was removed using a triple syringe if necessary[24, 30, 31]. The average time spent on the examination was almost 1 min per patient. The prosthodontist assessed the margins of the full-crown restorations according to the FDI[27] criteria, and the marginal fit of the full-crown restorations was rated as clinically acceptable (levels 1–3; 0) or unacceptable (levels 4 and 5; 1). The periodontist assessed the gingival status of the full-crown restorations according to the MGI[28], and the gingival status was rated as clinically acceptable (levels 0–2; 0) or unacceptable (levels 3 and 4; 1)
2.6 Intraoral photographs
After the clinical examination, intraoral photographs were taken under standardized conditions by a dentist trained in the use of photographic equipment[30]. The intraoral camera (Zhimei YF200B; Baden Co., Ltd.) had a 6-LED light source and provided images with a fixed resolution of 1,600 × 1,200.
The patients were positioned on a dental chair, with the Frankfort plane at an angle of 45° relative to the floor. No external light source was used. The teeth were wet when photographed, but excess saliva was removed using a sterile gauze or triple syringe. The position of the full-crown restorations was determined and a black and white calibration sheet was taped over one third of the buccal side. After covering the intraoral camera with a disposable protective sheet, it was inserted into the mouth and photographs of the restoration were obtained with the camera located 3 cm from the tooth surface[23]. The camera was positioned perpendicular to the buccal and lingual surfaces of the anterior teeth, at a 45° angle relative to the buccal and lingual surfaces of the posterior teeth (Fig. 2). After conventional intraoral photographs were obtained, two linear polarizers (Edmund Industrial Optics, Barrington, IL, USA) were perpendicularly placed in front of the light source and prism to enable cross-polarization. Owing to the cross-polarization, the horizontally polarized reflected light was blocked by the perpendicularly polarizing filter, such that the color distortion caused by specular reflection on the tooth surface was eliminated[26]. Photographs taken using the intraoral camera under these conditions were categorized as polarized. The photographs were evaluated for acceptability and quality; more photographs were obtained as needed.
The photographs were saved on a personal computer (Inspiron 5408; Dell Inc., Round Rock, TX, USA) as JPG files and assigned a numerical code to protect patient identity[24, 30]. The photographs from the conventional intraoral photographs group were imported into Photoshop CC 2018 (Adobe) for editing and processing (of the black and white calibration). These photographs were classified as calibration photographs and stored on the personal computer as JPG files. Sample photographs are displayed in Fig. 3.
2.7 Photographic evaluation
Three trained dentists who did not participate in the data collection process evaluated photographs showing the full-crown restoration margins and gingival status based on the FDI [27] criteria. Photographs from the conventional, calibration, and polarization groups were randomly displayed on a 14-inch high-definition display. Each evaluator independently assessed the photographs for 30 s and rated the full-crown restoration margins and gingival status as clinically acceptable (0) or unacceptable (1). Cases where at least two of three assessors were in agreement were analyzed[23].
2.8 Statistical analysis
The data were analyzed using SPSS software (version 26.0; IBM Corp., Armonk, NY, USA). The margins and gingival status of full-crown restorations were compared among the conventional, calibration, and polarization groups. Cohen's kappa statistic was used to assess the agreement between the intraoral camera-based assessments of the margins and gingival status of full-crown restorations and the clinical examinations. Kappa values were classified as poor (≤ 0.20), fair (0.21–0.40), moderate (0.41–0.60), good (0.61–0.80), or very good (0.81–1.00)[32].
The χ2 test was used to compare the assessment results among the three groups; p < 0.05 was considered to indicate a statistically significant difference.