Title: Clinical Effectiveness of Prefabricated Space Maintainers and Conventional Band and Loop Space Maintainers in A Paediatric Patients – A Split Mouth Randomized Clinical Trial.

Background:Space maintainers sms are used to preserve space created by premature loss of primary teeth. The most commonly used band and loop (B&L) smshave several demerits, e.g., non-functional, poor gingival health, limited survival, laboratory work for fabrication and multi-sitting procedure, etc. In order to overcome these disadvantages prefabricated space maintainers come into place. As Prefabricated band and loops require only one appointment, are quickly placed in a session, and do not require laboratory work; thus, they need less time and cost

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Aim:This study aims to compare and evaluate the efficacy of prefabricated space maintainers and conventional B&L SMs in terms of gingival health, survival time, and patients’ and parents’ satisfaction.

Study Groups:

In every patient, prefabricated SM in one quadrant while for the other quadrant, conventional Band and Loop will be delivered.

Group 1: Prefabricated Space Maintainer

Group 2: Conventional Band and Loop Maintainer

Outcome Measure:

·         gingival health

·         Survival time

·         Patient Satisfaction

·         Parent Satisfaction

METHODOLOGY:

It will be a prospective single Centre, single blind, parallel, Randomized clinical trial. Approval for the study will be obtained from the Institutional Ethical committee (IEC) of Priyadharshini dental college and hospital, Pandur.

·         Sample size determination

Power analysis will be done using latest software to determine the sample size

·         Patient selection

            The study participants will be recruited based on the eligibility criteria. The study will be carried out in the Department of Pedodontics and Preventive Dentistry at Priyadharshini Dental College and Hospital, Pandur, Tiruvallur, India

·         Randomization

                      Study participants will be randomized, based on computer-generated randomization and divided into two groups. Group A will be the Prefabricated band and loop and Group B will be Conventional band and loop. Participants will be allocated to two groups based on randomization.

·         Blinding

                     The patients and the Statistician involved in this study will be completely blinded.

·         Clinical Procedure

                         A complete medical and dental history will be obtained from the patient before commencing the treatment in the age group of 4–9 years with grossly mutilated single molars on either side, requiring extraction or freshly extracted single molars bilaterally in the same arch or opposite arch will be selected from the Outpatient Department of Paediatric and Preventive Dentistry. at Priyadharshini Dental College and Hospital, Pandur, Tiruvallur, India. Ethical clearance will be obtained before the study. Informed consent will be obtained from parents/guardians of the children participating in the study. For every selected child, a brief history will be taken followed by a clinical examination. Digital IOPA radiographs were taken for the tooth to be extracted. Impressions were made for study model preparation and space analysis. Patients will be divided into two groups based on random allocation (Lottery method).

In every patient, prefabricated SM in one quadrant while for the other quadrant, conventional Band and Loop will be delivered.

Group 1: Prefabricated Space Maintainer

Group 2: Conventional Band and Loop Maintainer

Both prefabricated SM and Conventional Banded SMs will be cemented using type I GIC (luting) Instructions on oral hygiene and appliance maintenance will be given to both children and parents.

• To brush daily with an orthodontic brush and fluoridated toothpaste twice.
• To rinse after every meal.
• To avoid consuming sticky food.

All the patients were recalled at the 1^st, 3^rd, 6th, 9^th month, and 1 year to compare their efficacy in terms of survival time, gingival health, and patients’ and parents’ satisfaction as per the following criteria:

Survival Time of SMs

Both SMs will be evaluated for de-cementation, de bonding, solder breakage, loop breakage, band breakage, and/or abutment tooth fracture.

Gingival Health of the Abutment Tooth

Gingival health of both the abutment teeth will be assessed according to the criteria given by Löe and Silness  in 1963 and the scores will be recorded at each follow-up visit.

Patients’ Satisfaction

Satisfaction of patients will be recorded using a 5-point Likert-type scale and the scores will be recorded at each follow-up visit.