The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.
Cooperative children (Positive or definitely positive) according to the Frankl's behaviour rating scale.
Children free of any systemic disease or special health care needs (ASA1).
Completion of an informed consent to participate in the study.
Second primary molar tooth with occluso-proximal carious lesions indicated for pulpotomy.
Clinical signs or symptoms of irreversible pulpitis or non- vitality.
Radiographic signs of degeneration including internal or external root resorption, furcation involvement.
Pathologic mobility detected by placing the points of a pair of tweezers in the occlusal fossa and gently rocking the tooth buccolingually.
Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
Parallel
Cention Forte alkasite bioactive restorative material
Other interventionCention forte material will be used as a final restoration for pulpotomized second primary molars
Stainless steel crown
Other interventionThe control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars
Clinical performance of the restorations using Modified Ryge's Criteria
The clinical evaluation of the two restorations will be done using parameters of marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness, and secondary caries as per the modified United States Public Health Service (USPHS) Ryge's criteria. Scores for the modified Ryge's criteria are as follow: * alpha: represents the ideal or excellent condition of a restoration * bravo: indicates a clinically acceptable restoration with minor defects * charlie: indicates restoration is unacceptable clinically and should be replaced
The antibacterial effect of both restorations on salivary cariogenic bacterial count.
The saliva samples will be collected to assess microbiological colony count of S.mutan and lactobacilli at baseline, after 1 week, 1 month and 3 months.
Radiographic success of pulpotomized second primary molars in both groups
The success of pulpotomy procedure will be assessed radiographically using digital periapical xray after 6 and 12 months.
Gingival index
Gingival health will be assessed clinically at baseline, then after 3, 6 and 12 months using the gingival index score: Scores for the index indicate: 0: normal gingival 1. mild inflammation, sllight change in colour and slight edema. No bleeding on probing 2. Moderate inflammation: redness, edema and glazing. Bleeding on probing. 3. Severe inflammation: marked redness, edema and ulcerations. Tendency towards spontaneous bleeding
Plaque index
Gingival health will be assessed clinically using plaque index at baseline, then after 3, 6 and 12 months. Plaque index scores indicate: 0: No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in-situ only after application of disclosing solution or by using the probe on the tooth surface 2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Child satisfaction
The patient's perception of the treatment will be assessed by using the Facial Image Scale (FIS) that represents satisfaction, indifference, or dissatisfaction. A few minutes will be spent before each procedure to establish rapport with the child and to obtain some notion of the child's understanding of the meaning of those schematic facial expressions. After treatment, the child will be instructed to choose the face that best represented how he/she felt during the procedure.
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Noha Fouad
Lead sponsor
Alexandria University
Sponsor institution
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