None listed
Conditions
Brief summary
A randomized controlled trial comparing clinical performance and outcome of bulk fill composite against compomer applied to class II restoration of 2nd lower primary molars in children aged 5 to 9 years. The comparison is based on recurrence of decay and sensitivity to air blowing
Interventions
All cases diagnosed with primary lower 2nd molars class 2 caries will undergo inferior alveolar nerve block as regional anesthesia using topical benzocaine gel 20% and 2% lidocaine with 1/80000 adrenaline (Septodent) injected through 25 mm gauge 27 disposable needle (NEDTC). A rubber dam will be applied and mesial or distal class II cavity preparation will be performed followed by application of metal cervical matrix band with wooden wedges. Then total etching using 39% phosphoric acid and Futu
All cases diagnosed with primary lower 2nd molars class 2 caries will undergo inferior alveolar nerve block as regional anesthesia using topical benzocaine gel 20% and 2% lidocaine with 1/80000 adrenaline (Septodent) injected through 25 mm gauge 27 disposable needle (NEDTC). A rubber dam will be applied and mesial or distal class II cavity preparation will be performed followed by application of metal cervical matrix band with wooden wedges. Then total etching using 39% phosphoric acid and Futurabond™, (VOCO) is applied. The preparations will be distributed in a randomized way to be filled with one of the following materials: Dental bulk fill composite X-tra fill™, (VOCO)(Intervention arm 1) , Polyacid-modified resin composite Glasiosite Compomer™, (VOCO)(Intervention arm 2), and a resin composite applied by incremental technique Polofil Supra™, (VOCO)(Control arm). These preparations will be performed using a turbine handpiece (NSK) and diamond round and cutting burs in addition to composite finishing burs. The procedure lasts for 30 minutes in average. As all the procedures for all recruited cases are performed by single dentist (the principal investigator) who perform all three kinds of procedures with adherence to protocol proposed by himself. Also, photos are available for most cases in different stages of procedures. The children will be followed up 3, 6, and 12 months later for outcome evaluation. Clinical evaluation, procedures and follow up visits will be done in pediatric dentistry department in Damascus University on outpatient basis by a different dentist who is pediatric dentistry undergraduate with 3 years pediatric dentistry experience.
Sponsors
Prof. Mohamed Al Tinawi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
Caries of lower second primary molar in children with behavior rated as definitely positive (Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation) or positive (Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively) according to Frankl behavioral Scale modified by Salviov- Tinawi aged 5 to 9 years.
Exclusion criteria
Associated medical comorbidities or mental disabilities. Bad oral health situation. Presence of acute symptoms like pain or abscess formation. Rejection of recruitment by family or guardian.
Outcome results
None listed