Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied With Different Luting Cements
NCT Number: NCT06558747
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries|Dental Plaque|Dental Caries in Children
Interventions: PROCEDURE: Tooth Preperation|PROCEDURE: Cementation
Sponsor: Akdeniz University
Sex: ALL
Age: CHILD
Enrollment: 53
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2016-07-25
Completion Date: 2019-03-08
Locations: Department of Pediatric Dentistry, Akdeniz University, Antalya, Turkey

Summary:
This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:

Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.

Participants will:

- visit the clinic 1st,3rd,6th,12th months after the restoration.

Primary Outcome Measures: Retention Status, The clinical success of the crowns regarding the retention status was evaluated as either present or absent based on whether the crown remained on the restored tooth at each follow-up appointment. Crowns that were still in place during the follow-up visit were considered successful in terms of retention, while those that had decemented were considered unsuccessful., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary Outcome Measures: Pulpal Survival, Maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.|Plaque Index, The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by recording the plaque index (PI), at all follow-up visits. The PI was recorded based on the criteria established by Silness and Löe, with 0 being the best and 3 being the worst. The recorded scores were compared among the groups., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.|Gingival Index, The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by recording the gingival index (GI) at all follow-up visits. The GI were recorded based on the criteria established by Silness and Löe, with 0 being the best and 3 being the worst. The recorded scores were compared among the groups., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.|Probing Depth, The clinical success of a full-coverage restoration is also related to periodontal health. The impact of the luting cement on periodontal health was investigated by measuring the probing depth (PD) of each crown at all follow-up visits. PD was measured using a universal periodontal probe by probing the gingival sulcus. The gingival sulcus is the space between the free gingiva and the tooth. It has a V-shape and allows the periodontal probe to enter. Clinically, a healthy gingival sulcus depth ranges from 0.5 to 2 mm on the buccal and lingual surfaces, while a pocket depth of up to 3 mm is considered normal in the proximal areas. A deeper pocket depth is considered an indication of periodontal disease. The recorded scores were compared among the groups., Evaluations were conducted at the 1st, 3rd, 6th, 12th months.