Comparative evaluation of survival rate, space loss ,gingival health and patient acceptance of conventional band and loop space maintainer and prefabricated band and loop space maintainer-A randomized controlled trial

Research Question

How effective is prefabricated Band and Loop  space maintainers in terms of survival rate, space maintainance, gingival health and patient acceptance?

 Aim

To compare and evaluate the survival rate, space loss, gingival health and patient acceptance of prefabricated Band and Loop space maintainer with conventional Band and Loop space maintainer.

  Objectves

· To evaluate the survival rate,space loss and gingival health after the placement of conventional band and loop space mainatainer.

· To evaluate the survival rate,space loss and gingival health after the placement of Prefabricated band and loop space mainatainer.

· To compare the survival rate, space loss, gingival health and patient acceptance of prefabricated Band and Loop space maintainer with conventional Band and Loop space maintainer.

Null Hypothesis

There is no significant difference in survival rate, space maintainance, gingival health and patient acceptance between Prefabricated Band and Loop space maintainers and  conventional Band and Loop space maintainers.

   Alternate Hypothesis

Prefabricated Band and Loop space maintainers are better than conventional Band and Loop space maintainer in terms of survival rate, space maintainance, gingival health and patient acceptance

Study design

Randomized Controlled Trial-split mouth design

  Study setting

Department of Pediatric and Preventive Dentistry, Malabar Dental college and Research Centre. ,Manoor,Edappal,Malappuram

Sample size A sample size of 36 sites/18 patients  (18 sites for one group) was calculated with an effect size of 1.2  (Thakur B et al, Scientific reports 2024) and a significance level  0.05 (5%) which would yield 90% power to detect a significant difference.

  Inclusion criteria

Clinical criteria

· Children of age   4-8 years

· Freshly extracted molar bilaterally in same arch or contralateral side of opposite arch

· Grossly mutilated single first molars bilaterally in the same arch or contralateral side in opposite arch which are indicated for extraction.

 Radiographic criteria

· Absence of any periapical  pathology with the abutment tooth.

· Presence of succedenous tooth bud.

· Presence of more than 1mm of bone overlying the succedenous tooth germ or less than one -third the root of permenant tooth formed.

  Exclusion criteria

· Absence of tooth in the mesial or distal side of the tooth to be extracted.

· Children with Special health care needs.

  Materials And Methodology

Recruitment

Children visiting the Department of Pediatric and Preventive Dentistry, Malabar Dental college and Research Centre, Edappal will be recruited  for the study based on inclusion and exclusion criteria.

 Informed consent

Informed consent will be obtained  from the patient’s parent or the guardian  using consent form

 Randomization

The eligible participants will be randomly allocated based the site and order of cementation to one of the four  groups by sealed envelope method. The child shall be asked to pick an envelope.

· E1 -Prefabricated band and loop space maintainer on left in first appointment

· E2- Prefabricated band and loop space maintainer on right in first appointment

· E3- Prefabricated band and loop space maintainer on left in second appointment

· E4- Prefabricated band and loop space maintainer on right in second  appointment

  Armamentarium

Isolation and infection control

• Gloves.

• Mouth mask.

• Cotton roll.

• Suction tips.

Diagnostic and Preparatory Instruments

• Kidney tray.

• Mouth mirror.

• Explorer.

 Band fabrication and fitting Instruments

· Prefabricated band and loop space maintainer (kedodental S-Fit)

• Stainless steel 0.036-inch wire.

• Band material (0.005 by 0.180 by 2 inches )

• Hoe plier.

• Band pusher.

• Band seater.

• Band remover.

• Three-prong plier.

• Welding machine

·  Silver solder

·  Flux

·  Soldering Machine

·  Hand Trimmer

·  Polishing burs.

·  sand paper

• Wire Cutter

·  Band cutting Scissors.

 Impression materials and instruments

• Impression tray.

• Alginate impression material.

·  Rubber bowl

·  Mixing spatula

• Dental stone.

 Cementation materials and instruments

• Glass ionomer cement-Type 1

·  Mixing pad

·  Agate spatula

  Procedure

Intraoral periapical radiographs will be  taken in areas of tooth to be extracted using Bisecting angle Technique. Impression using alginate and stainless steel impression trays wiil be taken for every patient and study models will be prepared .Measurement and recording of space present between primary canine and primary second molar preoperatively will be done using preoperative cast and radiographs. Oral prophylaxis and other restorative treatments will be carried out before the placement of space maintainer.

Fabrication

Test Group -Prefabricated Space maintainer

The mesiodistal diameter of the abutment tooth will be measured using a  Vernier caliper.A preformed band with a loop will be selected (Kedo S-Fit,Kedodental ,India).It will be made sure that it covered the entire surface of the tooth.A prefabricated loop will be selected based on available mesiodistal space and buccolingual breadth.The excess length of the loop will be cut off using a regular orthodontic cutter if present.The free ends of selected loop will be cemented on the band tube with luting GIC.

 Control Group - Prefabricated Space maintainer

The band strip (0.005 by 0.180 by 2 inches ) is contoured in an occclusogingival direction using contouring plier .The end of the strip of the band material is  welded and located on the tooth in desired position and festooning and Trimming will be performed wherever required and excess will be cutoff .The small remenant is folded against the lingual surface of tooth followed by welding procedure. The band is then placed on tooth and impression will be taken using  stainless steel impression trays and alginate.The band is then transferred from patient mouth to the impression and is  stabilized.The cast is poured using dental stone.Fabrication of the loop will  done using stainless steel 19 gauge wire and three prong plier and universal plier.Then the loop will be soldered on to the contoured band. Finishing and polishing will be done .The principal investigator  will perform all the laboratory work for all the study space maintainer .

 Cementation

After the impression an appointment will be given  for tooth extraction followed by cementation of either prefabricated or conventional band and loop space maintainers according to the randomization.Cementation of other space maintainer will be done after 7 days .cementation of  Space maintainers wil be done using type 1 GIC (Fuji X ).Patients will be instructed not to eat or drink with 30 minutes post cementation.Oral hygiene instructions will be given to both children and parent .

 Follow up assessments

Patients are recalled at 1,3 and 6 months. The patients are evaluated under the following

·           Survival rate

·           Space loss

·           Gingival health

·           Patient acceptance

Outcome measurement

Survival time of space maintainers

To evaluate he survival time , Both space maintainers are checked for cement loss, Failure of soldering, Distortion of the band ,Loop fracture. The evaluation will be done by visual inspection and with explorer and mirror .The evaluation  will be done in 1,3,and 6 month intervals. Outcomes are recorded in evaluation sheets

 Space loss

The distance between the midpoint of mesial surface of primary first molar and  midpoint of the distal surface of primary canine in both quadrants will be measured using a digital caliper in each followup.Measured values are recorded  in evaluation form.

Gingival Health

The gingival health is assessed. By Gingival  index by Silness and Loe (1963) . Evaluation will be done by visual inspection and with explorer and mirror.Inspection of the Buccal,mesial,lingual and distal  side of the abutment is done and appropriate score is assigned . Individual tooth score (GI Score) is calculated by sum of all scores divided by the number of sides. Evaluation is done  in each follow up visit in 1,3and 6 months .The data is recorded in evaluation forms.

Patient acceptance

Patient acceptance is evaluated in terms of level of comfort during the placement of space maintainer and by asking a series of questions.

· The  level of comfort  during the placement of space maintainers is evaluated using Wong Baker’s pain /discomfort scale

· Wong Baker’s Scale – It has a six row of faces ranging from no hurt to worst hurt, it evaluates the pain and discomfort of the child. The patient is asked to point at the face they felt most like at the moment. The faces 3,4 and 5 indicate high dental pain.

· the evaluation of comfort  will be done by the child him/herself in evaluation forms.

· Patient acceptance will be evaluated by asking a series of questions to parent.

· All the collected Data will be transferred to a data extraction sheet for statistical analysis.

 · Plan of Analysis

Data will be analyzed using the statistical package SPSS 26.0 (SPSS Inc., Chicago, IL) and level of significance will be set at p<0.05. Descriptive statistics will be performed to assess the mean and standard deviation of the respective groups. Normality of the data will be assessed using Shapiro Wilk test. Based on the Normality of the data, Inferential statistics to find out the difference between the groups will be done using  Independent T test /Mann Whitney U test. Within group analysis will be done using RM ANOVA test/ Friedman test. Categorical data will be analysed using chi square test. Kaplan Meier  analysis will be done for survival analysis.