Gingival HealthNCT06929754
To Compare the Effects of Lip Bumper Appliance in Rate of Lower Incisor Alignment After First Premolar Extractions
A study testing Lip bumper in people with Gingival Health and Crowding of Anterior Mandibular Teeth, run by Bahria University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Health, Crowding of Anterior Mandibular Teeth
- What is being tested?
- Lip bumper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rate of Lower Incisor Alignment and Periodontal Condition in Orthodontic Patients Undergoing Lip Bumper Treatment and Control Group After First Premolar Extractions- A Randomized Clinical Trial
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
Read the detailed description
A randomized clinical trial will be conducted, after seeking approval from the Ethical Review Committee of the institution. Patients will be included in the study after taking their consent through an informed consent form, records and finalization of their treatment plans for orthodontic treatment based on inclusion and exclusion criteria. Participants under 18 years of age will consent verbally while their parents or guardian will sign the consent form. A clause for consent of participants under 18 years of age has been included in the informed consent form both in English and Urdu versions. The inclusion of a control group with the same extraction pattern as in lip bumper group will minimize the confounding effect of driftodontics in lip bumper group. Random allocation of patients in lip bumper and control group will be done by distribution of sealed envelope to participants in orthodontic OPD, the sequence of which is generated by clinical trial randomization tool. The envelope will contain either of the two titles as ''lip bumper group'' or ''control group''. The participant will be asked to choose one envelop without prior knowledge of the title inside. The choice of selection of envelope is entirely at participant's discretion, thus ensuring a randomized selection process. This approach guarantees that the participant's choices are independent and free from any selection bias.
Bands will be placed for lower first molars, this will be followed by impression taking of the lower arch for fabrication of lip bumper for the experimental group, while in the control group the bands will be cemented with glass ionomer cement. The lip bumper will be fabricated from 0.045 inch stainless steel round wire covered with a layer of acrylic. The acrylic will extend from canine to canine. The lip bumper will be located between the lower lip and lower anterior teeth with a 2 mm of distance between them and arm inserted into the tube of molar band on the lower 1st molar. It will be set 4-5 mm away from the buccal segments. The top of the shield will be positioned two-thirds from the incisal edge of mandibular incisors. The specifications will be made parallel to the specifications used by Davidovitch et al. Impressions will be taken at the start of treatment T0 and at 1 month intervals T1, T2, T3 for model analysis. Lower incisor crowding will be measured by Little's irregularity index while the gingival health will be recorded as gingival index, plaque index and bleeding on probing and scored as per the criteria mentioned below. For the experimental group one side extraction will be done a week before and the other side on the day of lip bumper insertion. The control group will get their extractions only, both groups will be recalled monthly for impression taking of lower arch, bonding of lower arch will be done after 3 months in both groups, once the data collection is complete. Oral hygiene instructions will be given to both control and experimental group and it will be reinforced on each monthly visit. A single calibrated examiner, the principal investigator, will be placing the bands, lip bumper, giving OH instructions as well as taking all the readings clinically as well as on the models.
- Being tested
- Lip bumper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip bumperOther
Lip bumper appliance will be given as intervention to Lip bumper group
| Study group | Role | What they receive |
|---|---|---|
| Lip bumper group | Experimental | Lip bumper will be given as intervention Receives: Other: Lip bumper |
| Control group | No intervention | No appliance will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
To analyze the effects of lip bumper therapy on oral hygiene as assessed by gingival index
The effects will be assessed for both groups and will be compared.
Gingival index:
The gingival index developed by Silness and Loe will be used to assess the clinical severity of gingivitis based on color, consistency, location and bleeding on probing. Instruments used will be a mouth mirror and a periodontal probe. The scoring will be done on index teeth which are #16, #12, #24, #36, #32, #44. Surfaces examined on each tooth are distofacial, facial, mesiofacial and lingual. The score of these 4 areas of the tooth will be added and divided by four to give the GI for the tooth.
Score 0 = Normal gingiva Score 1 = Mild inflammation Score 2 = Moderate inflammation Score 3 = Severe inflammation
Measured: 3 months
To analyze the effects of lip bumper therapy on oral hygiene as assessed by plaque index
Plaque index developed by Silness and Loe will be used to record the presence of supragingival plaque on all four tooth surfaces including distofacial, facial, mesiofacial and lingual. The readings will be written on a separate paper and the final average score after calculation will be filled in the proforma. To visualize the plaque, teeth will be dried with air only and staining will not be done. The following teeth will be examined #16, #12, #24, #36, #32, #44.
Score 0 = No plaque score 1 = Mild plaque along the gingival margin Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque
Measured: 3 months
To analyze the effects of lip bumper therapy on oral hygiene as assessed by bleeding on probing
Bleeding on probing will be recorded using the Gingival index (GI) by Silness and Loe. A periodontal probe is passed along the gingival crevice of index teeth as per GI and the readings will be recorded. Scoring criteria for bleeding on probing index:
Score 0 = No bleeding when a periodontal probe is passed along the gingival margins Score 1 = Isolated bleeding, spots visible Score 2 = Blood forms a confluent red line on margins Score 3 = Heavy or profuse bleeding
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Mar 2025
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tooba Siddiqui, Bahria University
- Investigators
- Tooba Siddiqui T Tooba Siddiqui, Principal investigator, Bahria University Dental College, Bahria University Health Sciences Campus karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929754
- Sponsor's protocol ID
- BahriaUni_RCT
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rate of Lower Incisor Alignment and Periodontal Condition in Orthodontic Patients Undergoing Lip Bumper Treatment and Control Group After First Premolar Extractions- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06929754
- Acronym / sponsor ID
- BahriaUni_RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A randomized clinical trial will be conducted, after seeking approval from the Ethical Review Committee of the institution. Patients will be included in the study after taking their consent through an informed consent form, records and finalization of their treatment plans for orthodontic treatment based on inclusion and exclusion criteria. Participants under 18 years of age will consent verbally while their parents or guardian will sign the consent form. A clause for consent of participants under 18 years of age has been included in the informed consent form both in English and Urdu versions. The inclusion of a control group with the same extraction pattern as in lip bumper group will minimize the confounding effect of driftodontics in lip bumper group. Random allocation of patients in lip bumper and control group will be done by distribution of sealed envelope to participants in orthodontic OPD, the sequence of which is generated by clinical trial randomization tool. The envelope will contain either of the two titles as ''lip bumper group'' or ''control group''. The participant will be asked to choose one envelop without prior knowledge of the title inside. The choice of selection of envelope is entirely at participant's discretion, thus ensuring a randomized selection process. This approach guarantees that the participant's choices are independent and free from any selection bias.
Bands will be placed for lower first molars, this will be followed by impression taking of the lower arch for fabrication of lip bumper for the experimental group, while in the control group the bands will be cemented with glass ionomer cement. The lip bumper will be fabricated from 0.045 inch stainless steel round wire covered with a layer of acrylic. The acrylic will extend from canine to canine. The lip bumper will be located between the lower lip and lower anterior teeth with a 2 mm of distance between them and arm inserted into the tube of molar band on the lower 1st molar. It will be set 4-5 mm away from the buccal segments. The top of the shield will be positioned two-thirds from the incisal edge of mandibular incisors. The specifications will be made parallel to the specifications used by Davidovitch et al. Impressions will be taken at the start of treatment T0 and at 1 month intervals T1, T2, T3 for model analysis. Lower incisor crowding will be measured by Little's irregularity index while the gingival health will be recorded as gingival index, plaque index and bleeding on probing and scored as per the criteria mentioned below. For the experimental group one side extraction will be done a week before and the other side on the day of lip bumper insertion. The control group will get their extractions only, both groups will be recalled monthly for impression taking of lower arch, bonding of lower arch will be done after 3 months in both groups, once the data collection is complete. Oral hygiene instructions will be given to both control and experimental group and it will be reinforced on each monthly visit. A single calibrated examiner, the principal investigator, will be placing the bands, lip bumper, giving OH instructions as well as taking all the readings clinically as well as on the models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lip bumper group | Experimental | Other: Lip bumperLip bumper will be given as intervention |
| Control group | No intervention | –No appliance will be given |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lip bumperLip bumper appliance will be given as intervention to Lip bumper group | Other | Lip bumper group |
Primary outcome
To compare the rate of lower incisor alignment in orthodontic patients undergoing lip bumper treatment and control group after all first premolar extractions
Time frame: 3 months
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 secondary outcomes
To analyze the effects of lip bumper therapy on oral hygiene as assessed by gingival index
Time frame: 3 months
To analyze the effects of lip bumper therapy on oral hygiene as assessed by plaque index
Time frame: 3 months
To analyze the effects of lip bumper therapy on oral hygiene as assessed by bleeding on probing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tooba Siddiqui T Tooba Siddiqui principal investigator
Bahria University Dental College, Bahria University Health Sciences Campus karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lip bumper in people with Gingival Health and Crowding of Anterior Mandibular Teeth, run by Bahria University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the rate of lower incisor alignment in orthodontic patients undergoing lip bumper treatment and control group after all first premolar extractions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.