Home » Trials » SLCTR/2025/029


Comparison of treatment outcomes of cementing molar bands versus bonding molar tubes in permanent first molars in adolescent patients during the initial phase of orthodontic treatment: a split-mouth randomized controlled trial

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SLCTR Registration Number

SLCTR/2025/029


Date of Registration

20 Aug 2025

The date of last modification

Aug 20, 2025



Application Summary


Scientific Title of Trial

Comparison of treatment outcomes of cementing molar bands versus bonding molar tubes in permanent first molars in adolescent patients during the initial phase of orthodontic treatment: a split-mouth randomized controlled trial


Public Title of Trial

Comparison of treatment outcomes of cementing molar bands versus bonding molar tubes in permanent first molars in adolescent patients during the initial phase of orthodontic treatment: a split-mouth randomized controlled trial.


Disease or Health Condition(s) Studied

Malocclusion of teeth


Scientific Acronym


Public Acronym


Brief title


Universal Trial Number

U1111-1324-6624


Any other number(s) assigned to the trial and issuing authority

EC-25-050 (Faculty of Medicine, Colombo)


Trial Details


What is the research question being addressed?

Among molar tubes and molar bands used as terminal attachments in fixed orthodontic appliances, which provides better clinical outcomes in terms of attachment success rate, periodontal health and patient's perception in adolescent patients?"


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

Study setting: Orthodontic unit, Lady Ridgeway Hospital for Children, Colombo, Sri Lanka. Methods of randomisation: simple randomisation. Allocation: Group 1- molar bands in right upper permanent first molar and molar tubes in left lower permanent first molar and opposite in other quadrants. Group 2: molar tubes in right upper permanent first molar and molar bands to left lower permanent first molar and opposite will be done in other quadrants. Procedure that both groups will undergo: The first molars to receive bands will be placed separators for one week and following which the bands will be cemented using glass ionomer cement available in orthodontic unit. Molar bands with McLaughlin, Bennett, and Trevisi (MBT) prescription will be chosen for all first molars which will be bonded. Prior to fixing the attachments both groups will be asked to brush their teeth. The teeth to receive tubes will be isolated with cotton rolls and saliva ejector. 37% orthophosphoric acid etchant will be applied for 15 seconds, then rinsed and dried. Primer will be applied and molar tubes with MBT prescription of upper first molar and lower first molars will be bonded. The same commercial brand of glass ionomer cement and composite will be used for all patients following the manufacturer instructions and one operator will perform all the clinical steps. The remainder of teeth will be bonded with MBT brackets and initial arch wires will be placed immediately after bonding other teeth and followed their routine orthodontic treatment procedures. o The Bleeding of probing, calculus and periodontal health will be assessed preoperatively , 6th month , 12th month. o All patients will be given the same oral hygiene instructions and dietary instructions. o The bond or cement failure leading to attachment loosening or breakage will be regarded as failure. o The success or failure of molar band or tube will be documented with the tooth number along with the details of patient on the review appointment. At the same visit, the tooth will be banded or bonded again based on the assigned group, and the treatment will continue routinely. o Patient perception questionnaire will be administered by independent trained dental surgeon who is not involved in cementing molar band or bonding molar tube or outcome assessment to reduce response bias at 6th month All patients will receive standardized oral hygiene and dietary instructions at the baseline visit and during follow-up appointments. Compliance with oral hygiene instructions will be assessed subjectively, and reinforcement will be provided at each visit to ensure adherence to the recommended oral care practices.


Inclusion criteria

• Age: between 12-18 years for both sexes • Fully erupted permanent dentition having all teeth except third molars • Patients requiring fixed appliance in both arches • Patients having both extraction and non-extraction treatment protocols • Patients with stable mental health who can maintain good oral hygiene and maintain safety of brackets


Exclusion criteria

• Patients with missing or extracted or planned extraction of any of the first permanent molars • Patients having first permanent molars with evidence of demineralization, caries, and developmental enamel defects • Patients with any buccal restorations in first permanent molars with amalgam /composite /glass ionomer cements/ crowns that may interfere with banding or bonding. • Patients having poor oral hygiene and evidence of periodontal disease exhibiting pocket depth more than or equal to 4mm, bleeding on probing score more than or equal to 30 % of sites, visible supragingival or subgingival calculus on examination. • Patients having malocclusions that could predispose to debonding bonded tubes such as severe deep bite, unilateral or bilateral posterior crossbite and severe crowding (> 8mm arch discrepancy • Patients who require extra oral and intra oral anchorage appliances in addition to fixed appliance such as head gear, transpalatal arches and temporary anchorage devices • Patients who need expansion of their arches using quad helix for correction of transverse discrepancy • Patients with craniofacial anomalies



Primary outcome(s)

1.

The overall success rate percentage=Number of successful attachments/Total number of treated sites x100 with regard to molar bands and molar tube.

[

at 6 months and 1 year

]
2.

Periodontal health indicators: Bleeding on probing, presence of calculus, probing pocket depth with regard to molar bands and molar bands.For bleeding on probing and presence of calculus percentages will be calculated as Number of sites of the tooth with bleeding/presence of calculus /total number of sites assessed x 100 -Mean probing pocket depths will be compared among molar band and molar tubes groups .

[

at baseline, 6-months and 1-year.

]

Secondary outcome(s)

1.

Patient perceptions regarding molar bands versus molar tubes with regard to comfort, gingival swelling, bleeding during brushing, food impaction, cleaning difficulty, and overall preference.

[

In 6-months

]
2.

Factors associated with success rate of cemented molar bands and bonded molar tubes such as age, gender, parent's occupation and malocclusion.

[

At the time of cementing molar bands or bonding molar tubes and in 1 year

]

Target number/sample size

124 teeth (62 Molar band sites and 62 Molar tube sites)


Countries of recruitment

Sri Lanka


Anticipated start date

2025-09-01


Anticipated end date

2026-09-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Investigator funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2025-06-19


Approval number

EC-25-050


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Colombo.
Institutional Address:Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo 8, Sri Lanka.
Telephone:0112695300
Email: info.ethics@med.cmb.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Keerththana Balabaskaran
Senior Registrar in Orthodontics
Post Graduate Institute of Medicine, UOC Colombo.
0112693177
0772950405

drkeerththana@gmail.com

Contact Person for Public Queries

Dr. Irosha Perera
Consultant in Community Dentistry
Preventive Oral Health Unit, National Dental Hospital (Teaching) Sri Lanka.

071 4934258

irosha666rukmali@gmail.com


Primary study sponsor/organization

Orthodontic Unit, Lady Ridgeway Hospital for children

Dr Danister De Silva Mawatha, Colombo 00800
0112693711


Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results