Follow-up and assessment protocol
fracture, incisors, caries, tooth, dentin/based
IMPACTION, INFLAMMATION, MINOR, GINGIVAL BLEEDING, CARIES, SECONDARY, PLAQUE, CAVITY, PATHOLOGY
The restoration was assessed clinically by two experienced calibrated assessors immediately, after 6 months and one year. Calibration sessions were arranged for the two examiners prior to the initiation of the study as only experienced examiners with sufficient training and after proper calibration at ≥ 85% level will guarantee a reproducible result. Training procedures involves measuring the extent to which examiners record the same scores for the same phenomena before the beginning of study in order to reach kappa values of intra-examiner and inter-examiner agreement of ≥ 0.8. The primary, secondary, and tertiary outcomes were assessed following the FDI criteria as follows; esthetic evaluation as a primary outcome, marginal integrity as a secondary outcome, and patient satisfaction as a tertiary outcome. Esthetic evaluation involves the esthetic anatomical form, proximal anatomical form, periodontal response, and marginal staining. The secondary outcome involves clinical and radiographic marginal adaptation. The third outcome involves the patient's view in the forms of phonetics and food impaction [The outcomes of this clinical trial were assessed by the magnifying loupes in the form of a scoring system. For esthetic evaluation, the proximal anatomical form was given a score (1) when the contact point was normal and the floss could pass. Score (2) was given when the contact was slightly too strong, while the floss could pass. For the esthetic anatomical form, score (1) was given when the form was ideal according to width length ratio as the teeth length and width were measured by the digital caliper. Score (2) when there was slightly deviated from normal, and score (3) was given when the form deviates from normal but was still esthetically acceptable.Regarding periodontal response (adjacent mucosa and oral and general health) it was assessed by the presence of plaque and gingival inflammation, plaque assessment was done by using the bioclear disclosing agent. Score (1) represent the absence of plaque and inflammation. Score (2) where there was little plaque without gingival inflammation. Score (3) was obtained when the plaque accumulation was at an acceptable level and gingival bleeding was acceptable the restoration took score (3). For marginal staining score (1) when there was no staining. Score (2) was obtained when there was minor staining but easily removable. While score (3) was obtained with moderate staining.Radiographic marginal integrity and adaptation were assessed by using digital radiography, standardized radiographs were taken preoperative and immediately after the restoration (baseline), six months and one year later using an anterior parallel periapical kit. The Digora Optime DXR-50 001 digital intraoral imaging plate system (SoredexFinland) and Size 2 photostimulable phosphor plate (Soredex Corp., Tuusula, Finland) were used. The x-ray machine (Minray, Soredex-Finland) was programmed with the following settings: 70kVp, 7 mA, and 0.12 s exposure time. The exposure parameters were set for all patients at the start and throughout the study. The image plate was scanned by the Digora Optime DXR-50 001 (Soredex-Finland) digital scanner after the patient was radiographed. The Digora for Windows (DFW) 2.5 software program was used to analyze the images that were displayed on the computer monitor (Soredex-Finland).score (1) was obtained when no pathology harmonious transition between restoration and tooth, score (2.1) was given when the excess was acceptable, score (2.2) was representing positive\negative step at margin smaller than 150 μm, score (3.1) was obtained when the marginal gap was smaller than 200 μm, and score (3.2) was giving when negative steps visible smaller than 250 μm with non-noticable adverse effects, score (3.3) was representing a poor radio-opacity of the filling material. The score (4.1) was representing marginal gap larger than 250 μm, the score (4.2) was representing excess accessible but not removable, the score (4.3) was representing negative step larger than 250 μm but repairable, the score (5.1) was representing secondary caries or large gaps and the score (5.2) was representing the loss of restoration.Marginal adaptation was assessed by visual-tactile examination with an FDI probe, score (1) was obtained when the restoration was with a harmonious outline, no gaps, and no discoloration, and (2.1) score was given when the marginal gap was (50 μm), (2.2) score was representing small marginal fracture removable by polishing, (3.1) score was obtained when the gap was smaller than 150 μm and not removable, 3.2 several small enamel or dentin fracture (4.1) was representing gap larger than 250 μm or dentin/based exposed, (4.2) score was representing chipping damaged margin, (5.1) score was given when the restoration was partial loose but in situ. (5.2) score was representing generalized major gap or irregularities. The tertiary outcome (patient view) in the forms of phonetics and food impaction, score (1) was obtained when the participant was entirely satisfied.The evaluation was done at baseline (T0) (immediate after restoration); (T6) after 6 months; (T12) after 12 months, each assessor at a time using a predesigned chart. Patients were instructed to brush their teeth regularly based on ADA dental health recommendations using a soft toothbrush (Oral-B Toothbrush Ultrathin, Oral-B, USA) and regular fluoridated toothpaste (Signal Cavity Fighter Toothpaste, USA) that were provided to the participants by the operator every six months on recall periods and follow-up assessment visits. Restorations were given scores of 1–5, where 1 is clinically excellent, and 5 is clinically poor. Restorations receiving scores 1–3 are considered successful, while 4 and 5 are failed restorations requiring repair or replacement (Fig. a epresentative preoperative photograph for black triangle between maxillary central incisors for bioclear matrix group. a Representative preoperative photograph for black triangle between maxillary central incisors for conventional celluloid matrix group. 