Orthodontic Pain (D013850)SEP-ORTHONCT07532044
Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation
A study testing Elastomeric Separator, Kesling Separator and Tie wire separator in people with Orthodontic Pain (D013850) and Malocclusion, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain (D013850), Malocclusion, Orthodontic Treatment
- What is being tested?
- Elastomeric Separator, Kesling Separator and Tie wire separator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2026to 10 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding
- Age between 12 and 25 years
- Good oral hygiene (Plaque Index score 0-1)
- Good general oral health
- No previous orthodontic treatment
- No history of dental extractions
- Presence of tight interproximal contacts at the site of separator placement (no spacing)
Who cannot join
- Presence of interproximal restorations
- Presence of interproximal caries
- Missing maxillary second premolar, first molar, or second molar
- Unerupted maxillary second molars
- Systemic diseases affecting oral health (e.g., diabetes mellitus)
- Regular use of medications affecting pain perception (e.g., analgesics, corticosteroids)
- Loss of separators before follow-up appointment
- Failure to return within 72 hours for evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Islamabad Dental Hospital
Islamabad, Federal, 45720
Dr Sofia Riaz, BDS, MDS, +92 3465001484, sofia.riaz@iideas.edu.pk
About this study
Official title: Separation Effect, Plaque Score, Pain Perception, And Impact On Quality Of Life When Comparing Three Types Of Orthodontic Separators: A Randomized Controlled Trial
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.
This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.
Read more
In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.
Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
Read the detailed description
Separation of teeth prior to molar banding is an essential step in fixed orthodontic treatment. Orthodontic separators are used to create sufficient interproximal space to allow proper placement of bands. However, separator placement is commonly associated with pain, discomfort, and changes in oral hygiene practices, which may lead to plaque accumulation and negatively impact patients' quality of life.
Various types of orthodontic separators are available, including elastomeric separators, spring-type separators such as Kesling separators, and customized separators such as ligature tie wire separators. Elastomeric separators are widely used due to ease of placement; however, they may cause significant pain and are prone to dislodgement. Kesling separators are effective in tight contact areas but may cause gingival irritation and are relatively difficult to handle. Tie wire separators, which can be fabricated chairside, may offer a cost-effective and practical alternative, especially in cases with tight interproximal contacts.
This randomized controlled trial aims to compare three types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of:
Amount of separation achieved Pain perception using a visual analogue scale (VAS) Plaque accumulation measured using the Silness and Loe plaque index Impact on patients' quality of life assessed through structured interviews
A total of 144 participants requiring fixed orthodontic treatment with molar banding will be randomly allocated into three groups. Separators will be placed on the mesial and distal surfaces of maxillary first molars. Clinical parameters will be assessed after 48-72 hours.
Quantitative data will be analyzed using appropriate statistical tests, including one-way ANOVA and Chi-square tests. Additionally, qualitative data from patient interviews will be analyzed using thematic analysis to explore the impact of separator placement on daily life, including functional, emotional, and social aspects.
The results of this study will help determine the most effective separator with minimal discomfort and adverse effects, thereby improving patient compliance and overall orthodontic treatment experience.
- Being tested
- Elastomeric Separator, Kesling Separator, Tie wire separator
- Keywords
- Orthodontic separators, Pain perception, Plaque index, Quality of life, Tooth separation
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastomeric SeparatorDevice
Elastomeric separators are polyurethane O-shaped orthodontic modules placed interdentally between the mesial and distal surfaces of maxillary first molars. They exert continuous elastic force to create interproximal space prior to molar band placement. In this study, separators will be placed bilaterally and left in situ for 48-72 hours before removal and clinical assessment of separation, pain, and plaque accumulation.
Kesling SeparatorDevice
Kesling separators are spring-type orthodontic separators fabricated from 0.020-inch stainless steel Australian wire with a helical loop design. The appliance has two arms, one engaging the lingual embrasure and the other positioned beneath the interproximal contact point, providing controlled separation force in areas with tight contact. In this study, Kesling separators will be placed bilaterally on the mesial and distal surfaces of maxillary first molars and left in situ for 48-72 hours prior to removal and clinical evaluation of separation, pain, and plaque accumulation.
Tie wire separatorDevice
Tie wire separators are orthodontic separators fabricated using 0.010-0.012 inch stainless steel ligature wire twisted and adapted interproximally around the contact area of posterior teeth. The wire is tightened and positioned to exert gradual separating force between the mesial and distal surfaces of maxillary first molars, facilitating creation of interproximal space for band placement. In this study, tie wire separators will be placed bilaterally and maintained in situ for 48-72 hours prior to removal and assessment of tooth separation, pain, and plaque accumulation.
| Study group | Role | What they receive |
|---|---|---|
| Elastomeric Separator Group | Other | Participants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. Receives: Device: Elastomeric Separator; Device: Tie wire separator |
| Kesling Separator Group | Active comparator | participants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. Receives: Device: Elastomeric Separator; Device: Kesling Separator |
| Tie Wire Separator Group | Experimental | Participants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. Receives: Device: Kesling Separator; Device: Tie wire separator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Tooth Separation Achieved
Interproximal separation between maxillary first molars measured using a leaf gauge (COMBO TECH incremental thickness gauge) on mesial and distal surfaces. Mean separation will be calculated.
Measured: 48 to 72 hours after separator placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Pain (D013850)Studies 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
- Model description
- Participants will be randomly assigned into three parallel groups. Each group will receive a different type of orthodontic separator (elastomeric, Kesling, or tie wire) placed on the mesial and distal surfaces of maxillary first molars. Outcomes will be assessed after 48-72 hours.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE), Study chair, Islamabad medical & dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532044
- Sponsor's protocol ID
- IDH111
- Other IDs
- IDH-ORTHO-2017-01
- Acronym
- SEP-ORTHO
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to maintain participant confidentiality and due to institutional data protection policies.
Publications
Patel S, McGorray SP, Yezierski R, Fillingim R, Logan H, Wheeler TT. Effects of analgesics on orthodontic pain. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e53-8. doi: 10.1016/j.ajodo.2010.07.017.
PubMed 21195257Malagan MA, P P B, Muddaiah S, Reddy R, Shetty BK, Preetham J, Naduwinmani S, Singh S. Comparison between efficacy of four different types of orthodontic separators. J Clin Diagn Res. 2014 Aug;8(8):ZC41-4. doi: 10.7860/JCDR/2014/9963.4755. Epub 2014 Aug 20.
PubMed 25302266Kumar BD, Chandra S, Singh RN, Shahi AK, Sharma S, Singh B. Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. J Contemp Dent Pract. 2022 May 1;23(5):508-512.
PubMed 35986458
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Separation Effect, Plaque Score, Pain Perception, And Impact On Quality Of Life When Comparing Three Types Of Orthodontic Separators: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07532044
- Acronym / sponsor ID
- SEP-ORTHO / IDH111
- Keywords
- Orthodontic separators, Pain perception, Plaque index, Quality of life, Tooth separation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 15 Apr 2026 (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.
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.
This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.
In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.
Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
Detailed description
Separation of teeth prior to molar banding is an essential step in fixed orthodontic treatment. Orthodontic separators are used to create sufficient interproximal space to allow proper placement of bands. However, separator placement is commonly associated with pain, discomfort, and changes in oral hygiene practices, which may lead to plaque accumulation and negatively impact patients' quality of life.
Various types of orthodontic separators are available, including elastomeric separators, spring-type separators such as Kesling separators, and customized separators such as ligature tie wire separators. Elastomeric separators are widely used due to ease of placement; however, they may cause significant pain and are prone to dislodgement. Kesling separators are effective in tight contact areas but may cause gingival irritation and are relatively difficult to handle. Tie wire separators, which can be fabricated chairside, may offer a cost-effective and practical alternative, especially in cases with tight interproximal contacts.
This randomized controlled trial aims to compare three types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of:
Amount of separation achieved Pain perception using a visual analogue scale (VAS) Plaque accumulation measured using the Silness and Loe plaque index Impact on patients' quality of life assessed through structured interviews
A total of 144 participants requiring fixed orthodontic treatment with molar banding will be randomly allocated into three groups. Separators will be placed on the mesial and distal surfaces of maxillary first molars. Clinical parameters will be assessed after 48-72 hours.
Quantitative data will be analyzed using appropriate statistical tests, including one-way ANOVA and Chi-square tests. Additionally, qualitative data from patient interviews will be analyzed using thematic analysis to explore the impact of separator placement on daily life, including functional, emotional, and social aspects.
The results of this study will help determine the most effective separator with minimal discomfort and adverse effects, thereby improving patient compliance and overall orthodontic treatment experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned into three parallel groups. Each group will receive a different type of orthodontic separator (elastomeric, Kesling, or tie wire) placed on the mesial and distal surfaces of maxillary first molars. Outcomes will be assessed after 48-72 hours.
| Arm | Type | Receives |
|---|---|---|
| Elastomeric Separator Group | Other | Device: Elastomeric Separator, Device: Tie wire separatorParticipants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. |
| Kesling Separator Group | Active comparator | Device: Elastomeric Separator, Device: Kesling Separatorparticipants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. |
| Tie Wire Separator Group | Experimental | Device: Kesling Separator, Device: Tie wire separatorParticipants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding
- Age between 12 and 25 years
- Good oral hygiene (Plaque Index score 0-1)
- Good general oral health
- No previous orthodontic treatment
Key exclusion criteria (8 listed)
- Presence of interproximal restorations
- Presence of interproximal caries
- Missing maxillary second premolar, first molar, or second molar
- Unerupted maxillary second molars
- Systemic diseases affecting oral health (e.g., diabetes mellitus)
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 |
|---|---|---|
| Elastomeric SeparatorElastomeric separators are polyurethane O-shaped orthodontic modules placed interdentally between the mesial and distal surfaces of maxillary first molars. They exert continuous elastic force to create interproximal space prior to molar band placement. In this study, separators will be placed bilaterally and left in situ for 48-72 hours before removal and clinical assessment of separation, pain, and plaque accumulation. | Device | Elastomeric Separator Group, Kesling Separator Group |
| Kesling SeparatorKesling separators are spring-type orthodontic separators fabricated from 0.020-inch stainless steel Australian wire with a helical loop design. The appliance has two arms, one engaging the lingual embrasure and the other positioned beneath the interproximal contact point, providing controlled separation force in areas with tight contact. In this study, Kesling separators will be placed bilaterally on the mesial and distal surfaces of maxillary first molars and left in situ for 48-72 hours prior to removal and clinical evaluation of separation, pain, and plaque accumulation. | Device | Kesling Separator Group, Tie Wire Separator Group |
| Tie wire separatorTie wire separators are orthodontic separators fabricated using 0.010-0.012 inch stainless steel ligature wire twisted and adapted interproximally around the contact area of posterior teeth. The wire is tightened and positioned to exert gradual separating force between the mesial and distal surfaces of maxillary first molars, facilitating creation of interproximal space for band placement. In this study, tie wire separators will be placed bilaterally and maintained in situ for 48-72 hours prior to removal and assessment of tooth separation, pain, and plaque accumulation. | Device | Elastomeric Separator Group, Tie Wire Separator Group |
Primary outcome
Amount of Tooth Separation Achieved
Time frame: 48 to 72 hours after separator placement
Interproximal separation between maxillary first molars measured using a leaf gauge (COMBO TECH incremental thickness gauge) on mesial and distal surfaces. Mean separation will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 21195257Patel S, McGorray SP, Yezierski R, Fillingim R, Logan H, Wheeler TT. Effects of analgesics on orthodontic pain. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e53-8. doi: 10.1016/j.ajodo.2010.07.017.
- Results publication: PubMed 25302266Malagan MA, P P B, Muddaiah S, Reddy R, Shetty BK, Preetham J, Naduwinmani S, Singh S. Comparison between efficacy of four different types of orthodontic separators. J Clin Diagn Res. 2014 Aug;8(8):ZC41-4. doi: 10.7860/JCDR/2014/9963.4755. Epub 2014 Aug 20.
- Results publication: PubMed 35986458Kumar BD, Chandra S, Singh RN, Shahi AK, Sharma S, Singh B. Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. J Contemp Dent Pract. 2022 May 1;23(5):508-512.
- Individual participant dataSharing planned: No. IPD will not be shared to maintain participant confidentiality and due to institutional data protection policies.
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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.
Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE) study chair
Islamabad medical & dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastomeric Separator, Kesling Separator and Tie wire separator in people with Orthodontic Pain (D013850) and Malocclusion, run by Islamabad Medical and Dental College 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sofia Riaz, BDS, MDS (+92 346 5001484, sofia.riaz@iideas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Tooth Separation Achieved (time frame: 48 to 72 hours after separator placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07532044, which also lists 3 linked publications.
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 8 May 2026.