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IRCT20200601047626N1 IRCT 2020-07-20 Research Department pf Islamic Azad University of Tehrran, DEntal Branh Primary molar reconstruction with direct composite crown - Clinical evaluation of primary molars crown reconstruction with stainless steel crown and direct composite crown 2020-07-22 anticipated 33 Complete https://irct.ir/trial/48828 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In each patients, teeth are selected for coverage with SSC or composite crown randomly. The first side to be treated is selected by coin tossing and the type of the crown is selected by opening the envelopes. N/A Primary teeth caries. Intervention 1: Intervention group: After pulp treatment, 2mm of zonalin (Golchay, Iran) is applied over the orifices as the deepest layer of the filling, then it is covered by a 1mm layer of lining glass ionomer (Willman and Peinn, Germany) in order to avoid the detrimental effect of zonalin on composite material. The interior walls are cleaned so that healthy dentinal walls were observed.A metal matrix band is applied and then retained with wedge. The interior walls and proximal box are etched with 37% phosphoric acid for 30 seconds and care is taken in order not to etch the lining glass ionomer. The etchant is rinsed with water for 20 seconds and then air dried . Dental bonding single bond (3M ESPE USA) is applied, air dried for 10 seconds and light cured for 20 seconds. The dual cure core build up material is injected into the tooth until the occlusal surface. After the chemical curing is finished, the tooth is light cured for 2 minutes (40 seconds from each side) . The rubber damn, matrix and wedge are removed and the SSC preparation is performed. 1,5 mm space between occluding teeth and 1mm space between adjacent teeth are achieved. After selection of the appropriate SSC and adjusting it on the tooth, a putty and wash impression is taken from the tooth covered by the SSC. This would give us the exact anatomy of the SSC for the later composite crown, so that the restoration could be an aesthetic replica of the SSC. The SSC is then removed and in order to achieve sufficient composite thickness around the tooth, outer supragingival walls are reduced 1mm with a fissure bur. Gingival bleeding is arrested by injection of access edge material (Centrix, USA) around the tooth. After injecting, the cotton role which is provided by the manufacturer is applied over the tooth, and the patient bites it for 2 minutes. Then the paste is washed out from the sulcus. If bleeding could not be stopped, the rest of the treatment is postponed to another session.In the next step the tooth is isolated with cotton roles and gingival cord and polytetrafluroethylene (PTFE) tapes are used to cover the adjacent teeth. Etching and bonding is performed as earlier mentioned. The core build up material is injected inside the impression, at the location of the prepared tooth. Cotton roles are removed and the tray is placed inside the mouth at the exact place. Tray is held with minimum pressure over the tooth for 5 minutes, so the chemical curing is assured to be completed, then the tray is removed and the composite is light cured for 40 seconds from buccal, lingual and occlusal separately. Restoration margins are checked and excess materials are removed if any present. Occlusion is checked and final finishing and polishing is done. The final step is to apply a thin layer of Biscover polishing liquid Biscover LV (Bisco, Schaumburg, IL, USA), over the restoration, to do that; first the composite is etched for 15 seconds and rinsed with water, then a thin layer of the liquid is applied is awaited to be there for 15 seconds and finally cured for 30 seconds. for final assessment of the restoration a bitewing radiography is achieved. Intervention 2: Control group: teeth in the control group are restored with SSC. Yes - There is a plan to make this available What will be shared: variants of 1st specific goal: 4-8 year old patient; cooperative patient (Frankel 1-2); both first primary molars of one jaw needs pulp treatment and crown restoration at least two healthy buccal and lingual walls be present which are supported by intact dentin with 2mm thickness absence of subgingival caries variants of 2nd specific goal: bleeding on probing; presence or absence of caries in bitewing radiography; catching with explorer; presence of fractures on enamel or dentin; mobile restoration; restoration's fracture or loss; marginal discoloration; crack or fracture on restoration variants of 3rd specific goal: parents' satisfaction by the appearance of the restoration all the potential data can be shared after unrecognization of the patients When: access is opened 6 months after publication of results To whom: researchers occupied in scientific and higher education facilities Conditions: for systematic review with permission of the researcher Where to obtain: parisa aref through email p_aref@dentaliau.ac.ir How to obtain: through email Comments:
public Parisa Aref
Islamic azad university of tehran, dental branch, Neyestan 9th, Pasdaran ave.,
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2268 6004 p_aref@dentaliau.ac.ir Islamic Azad University scientific Parisa Aref
Islamic azad university of tehran, dental branch, Neyestan 9th, Pasdaran ave.,
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2268 6004 p_aref@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) Both first primary molars of one of the dental archs require crown coverage after pulp treatment Each tooth has at least two intact buccal and lingual walls Proxogingival floor is supragingival and caries free Remaining walls should be supported by intact dentin and have the width of at least 2mm Patients should be cooperative Patients should be 4-8 years old 4 years 8 years Both Existing traumatic occlusion Teeth with pathological root resorption Teeth with root caries Teeth with hypoplastic lesions Patients with low oral hygiene based on OHI-S criteria - - Treatment - Other Treatment - Other Intervention group: After pulp treatment, 2mm of zonalin (Golchay, Iran) is applied over the orifices as the deepest layer of the filling, then it is covered by a 1mm layer of lining glass ionomer (Willman and Peinn, Germany) in order to avoid the detrimental effect of zonalin on composite material. The interior walls are cleaned so that healthy dentinal walls were observed.A metal matrix band is applied and then retained with wedge. The interior walls and proximal box are etched with 37% phosphoric acid for 30 seconds and care is taken in order not to etch the lining glass ionomer. The etchant is rinsed with water for 20 seconds and then air dried . Dental bonding single bond (3M ESPE USA) is applied, air dried for 10 seconds and light cured for 20 seconds. The dual cure core build up material is injected into the tooth until the occlusal surface. After the chemical curing is finished, the tooth is light cured for 2 minutes (40 seconds from each side) . The rubber damn, matrix and wedge are removed and the SSC preparation is performed. 1,5 mm space between occluding teeth and 1mm space between adjacent teeth are achieved. After selection of the appropriate SSC and adjusting it on the tooth, a putty and wash impression is taken from the tooth covered by the SSC. This would give us the exact anatomy of the SSC for the later composite crown, so that the restoration could be an aesthetic replica of the SSC. The SSC is then removed and in order to achieve sufficient composite thickness around the tooth, outer supragingival walls are reduced 1mm with a fissure bur. Gingival bleeding is arrested by injection of access edge material (Centrix, USA) around the tooth. After injecting, the cotton role which is provided by the manufacturer is applied over the tooth, and the patient bites it for 2 minutes. Then the paste is washed out from the sulcus. If bleeding could not be stopped, the rest of the treatment is postponed to another session.In the next step the tooth is isolated with cotton roles and gingival cord and polytetrafluroethylene (PTFE) tapes are used to cover the adjacent teeth. Etching and bonding is performed as earlier mentioned. The core build up material is injected inside the impression, at the location of the prepared tooth. Cotton roles are removed and the tray is placed inside the mouth at the exact place. Tray is held with minimum pressure over the tooth for 5 minutes, so the chemical curing is assured to be completed, then the tray is removed and the composite is light cured for 40 seconds from buccal, lingual and occlusal separately. Restoration margins are checked and excess materials are removed if any present. Occlusion is checked and final finishing and polishing is done. The final step is to apply a thin layer of Biscover polishing liquid Biscover LV (Bisco, Schaumburg, IL, USA), over the restoration, to do that; first the composite is etched for 15 seconds and rinsed with water, then a thin layer of the liquid is applied is awaited to be there for 15 seconds and finally cured for 30 seconds. for final assessment of the restoration a bitewing radiography is achieved. Control group: teeth in the control group are restored with SSC. Marginal adaptation. Timepoint: 3-6 months. Method of measurement: Examination with dental explorer. Gingival health. Timepoint: 3-6 months. Method of measurement: Probing. Secondary caries. Timepoint: 3-6 months. Method of measurement: Bitewing radiography. Marginal discoloration. Timepoint: 3-6 months. Method of measurement: Direct observation. Integrity. Timepoint: 3-6 months. Method of measurement: Examination with dental explorer and light. Parents' satisfaction with restoration's appearance. Timepoint: 3-6 months. Method of measurement: Questioning. Research Department pf Islamic Azad University of Tehrran, DEntal Branh Approved 2020-05-31 Ethics Committee of Islamic Azad University of Medical Sciences, Dental School No.9, Neyestan 9th Alley, Pasdaran Ave., Tehran. Tehran Tehran Iran (Islamic Republic of)