Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT07033650
Brief Summary:
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
Detailed Description:
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). The approval of Ethical committee of the Faculty of Dentistry, Suez Canal University, will be taken. This study will be carried on apparently healthy patients of age group 21-50 years, with at least three occluso-proximal cavitated dentinal lesion on the posterior molars, the patients who will agree to participate in this study will sign an informed consent. Also it will be reported according to the protocol established by CONSORT guidelines to ensure transparent and complete reporting.
Patients will be recruited from outpatient clinic of Operative Dentistry Department in Faculty of Dentistry, Suez Canal University. Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. The data from the study and consent forms will be written in Arabic so that every patient could understand them. Patients will be only admitted to the study after signing the informed consent.
Simple randomization will be assigned for 29 participants. Every patient will be diagnosed by examiners for three posterior class II carious lesions. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Assessment of restorations will be performed clinically by visual inspection using magnification loupes (4.5x; Carl Zeiss GmbH, Jena, Germany), dental mirrors, a light source and FDI recommended probes with different tip diameters of 150 and 250 micrometer diameter (150x and 250x, Deppeler, Switzerland) . These probes will be used specially for evaluation of both marginal adaptation (functional property) and tooth integrity of enamel cracks and tooth fractures (biological property). Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Transient pain brought on by stimulation will be acceptable, while persistent pain renders the restoration unacceptable and necessitates intervention to resolve the problem. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
Study:
NCT07033650
Study Brief:
Protocol Section:
NCT07033650