To Compare the Effects of Lip Bumper Appliance in Rate of Lower Incisor Alignment After First Premolar Extractions

NCT06929754 | Completed

• 1 other identifier: BahriaUni_RCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to check the effects of lip bumper appliance contribution to driftodontics after designated tooth extractions that are already part of orthodontic treatment plan. The main questions it aims to answer are:

• Is there a significant difference in rate of incisor alignment in lip bumper group?
• Does the lip bumper have any adverse effects on oral hygiene? Researchers will compare the effects of appliance vs no appliance. Participants will have:
• Appliance cemented in mouth after extractions in interventional group and no appliance in control group
• Three monthly follow up for checkup and impressions

Conditions

Gingival Health; Crowding of Anterior Mandibular Teeth

Outcome Measures

Primary Outcomes (1)

• To compare the rate of lower incisor alignment in orthodontic patients undergoing lip bumper treatment and control group after all first premolar extractions

  The effect on driftodontics will be assessed by little's irregularity index in both groups undergoing similar extraction pattern but one group with lip bumper and other as control. * 0 mm - Perfect alignment * 1-3 mm- Minimal irregularity * 4-6 mm- Moderate irregularity * 7-9 mm- Severe irregularity * 10 mm- Very severe irregularity

  3 months

Secondary Outcomes (3)

• To analyze the effects of lip bumper therapy on oral hygiene as assessed by gingival index

  3 months

• To analyze the effects of lip bumper therapy on oral hygiene as assessed by plaque index

  3 months

• To analyze the effects of lip bumper therapy on oral hygiene as assessed by bleeding on probing

  3 months

Study Arms (2)

Lip bumper group

EXPERIMENTAL

Lip bumper will be given as intervention

Other: Lip bumper

Control group

NO INTERVENTION

No appliance will be given

Interventions

Lip bumper OTHER

Lip bumper appliance will be given as intervention to Lip bumper group

Lip bumper group

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A treatment plan involving bilateral extractions of maxillary and mandibular first premolars
• Patients with class 1 and upto quarter cusp class 2 molar relationship
• Moderate to severe incisor irregularity of 4-9 mm as assessed by little's irregularity index
• Presence of all first molars

You may not qualify if:

• Developmental, medical or genetic problems
• Patients using bisphosponates
• Spacing in dentition
• Carious lesion in lower first molars which cannot be restored
• Patient with active periodontal disease
• Previous orthodontic treatment

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Bahria University Medical and Dental College

Karachi, Sindh, Pakistan

Location

Study Officials

• Tooba Siddiqui T Tooba Siddiqui

  Bahria University Dental College, Bahria University Health Sciences Campus karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 16, 2025
• Study Start: March 1, 2025
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-09

Locations

PA (1)