Gingival OvergrowthPhase 1NCT04030767
Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox
A Phase 1 study testing Botox Injectable Product in people with Gingival Overgrowth, run by Cairo University.
Trial summary
Since the introduction of the lip repositioning procedure by a number of modifications to the technique have been introduced. All these modifications were made to prevent the main complication of lip repositioning surgeries 'relapse'. Relapse was found to occur in 8% of the cases treated . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- Botox Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2019to 20 Sep 2022
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gummy smile more than 3mm.
- Adults >18 years.
- Non-smokers.
- Patients with healthy systemic condition
- Normal clinical crown dimensions.
- Good oral hygiene.
Who cannot join
- Natural dentition upper anterior
- Pregnant or lactating women.
- Patients with inflamed gingiva or gingival enlargement.
- Inflammation or infection at the site of injection.
- Patients with allergy to botulinum toxin, lactose, and albumin.
- Concurrent use of aminoglycoside antibiotic that enhances the action of the toxin. (Jaspers, Pijpe, \& Jansma, 2011)
- < 3 mm attached gingivae that might create difficulties in flap design, stabilization and suturing.
- Patients using anticholinesterase or other agents interfering with neuromuscular transmission
About this study
Official title: Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox: a Randomized Clinical Trial
Since the introduction of the lip repositioning procedure by a number of modifications to the technique have been introduced. All these modifications were made to prevent the main complication of lip repositioning surgeries 'relapse'. Relapse was found to occur in 8% of the cases treated .
Botox injections have been suggested as a possible treatment for cases with relapse Botox acts by blocking muscular activity, however, Botulinum toxin technique has a transitory effect (6-7 months). . By combining Botox as a pretreatment and lip repositioning surgery, Botox injections maybe a useful adjunct in improving and stabilizing the results of achieved, by paralyzing the muscles during the healing period.
There are no studies, to the investigator's knowledge, exploring the use of botox combined with lip repositioning to decrease muscle pull and therefore decrease the relapse.
Read the detailed description
Normal gingival display has been defined by as the gum exposure between the inferior border of upper lip and gingival margin of anterior central incisors when smiling. An exposure of gingiva around 0-2 mm when smiling, and 2-4 mm of the maxillary incisor edges when the lips are at the rest state are considered as acceptable. While more than 2 mm of gingival exposure when a person smiles is stated by experts as an excessive gingival display, or what is known as "Gummy Smile",which is more of a descriptive term than a diagnosed condition, and affects a notable proportion of the population, especially women who are affected more than men.
Many studies have stated the main causes of excessive gingival display, presenting the most important factors which may lead to having a gummy Smile. The study of Roe described that lip length and the upper lip mobility rate are the main contributing factors. The previous research stated that the exposure of teeth and gingiva depends on the integrated effects of a number of variables (increased muscle capacity, vertical maxillary excess, greater inter-labial gap at resting position, and the amount of over-jet and over-bite). Pausch \& Katsoulis mentioned that abnormal gingival and maxillary anterior teeth display may take place due to numerous anatomic or functional factors, either hereditary or inborn. A narrow upper lip, an irregular eruption of teeth, excessive protuberance or vertical maxillary growth, and hypermobility of the maxillary lip and elevator muscle are common reasons for a gummy Smile. In fact, several contributing factors are affecting individuals to have a gummy Smile. Sometimes one of them is presented, although in some cases more than only one cause can be seen. Correct diagnosis of the reason leads to a proper treatment plan.
Excessive gingival display can be managed by a variety of procedures. These procedures include surgical and non-surgical methods The underlying cause of excessive gingival display or gummy Smile has the main effect on the type of procedure that will be performed.
- Conditions
- Gingival Overgrowth
- Being tested
- Botox Injectable Product
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Injectable ProductDrug
Also called Xeomin
Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity
| Study group | Role | What they receive |
|---|---|---|
| lip repositioning technique with Botox injection. | Experimental | Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity (Binder et al., 1998).
Therefore, the technique is a useful adjunct in the esthetic improvement of the smile and provides better results when combined with resective gingival surgery(Pedron \& Mangano, 2018). Receives: Drug: Botox Injectable Product |
| lip repositioning technique. | Active comparator | Lip repositioning aims to limit the retraction of elevator smile muscles. Lip repositioning results in a shallow vestibuler restricting of the muscle pull; Thereby limiting the gingival display during smiling.(Makkiah, 2017) It is a less invasive, viable substitute for patients, has fewer post-operative complications and provides a faster recovery compared to orthognathic surgery(Grover, Gupta, \& Luthra, 2014). Receives: Drug: Botox Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in amount of gingival display
Amount of gingival display (from the inferior border of the upper lip vermillion border to the gingival margin of the central incisor) will be assessed from clinical photographs obtained during active smile, with a mm ruler in place
Measured: recorded at baseline, 3, 6 ,9 months and 1 year
Secondary outcomes (1)
Patient satisfaction: quesionnaire
On the first follow-up visits, each patient from both groups answered a questionnaire addressing the following aspects:
- The overall appearance.
- Rate the improvement of their smile according to a 5-point aesthetic scale (5 = excellent, 4 = very good, 3 good, 2 = fair, 1 = poor).
- Their willingness to repeat the treatment.
Measured: o The level of satisfaction during the followed periods (after two weeks, after two months, after six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Sep 2019 (estimated)
- Primary completion20 Sep 2020 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Trial: Parallel group, two arm, non-inferiority trial with 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ola mostafa ghoniem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030767
- Sponsor's protocol ID
- 2261986
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04030767
- Acronym / sponsor ID
- 2261986
- Conditions
- Gingival Overgrowth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2019 (estimated)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 24 Jul 2019 (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.
Since the introduction of the lip repositioning procedure by a number of modifications to the technique have been introduced. All these modifications were made to prevent the main complication of lip repositioning surgeries 'relapse'. Relapse was found to occur in 8% of the cases treated .
Botox injections have been suggested as a possible treatment for cases with relapse Botox acts by blocking muscular activity, however, Botulinum toxin technique has a transitory effect (6-7 months). . By combining Botox as a pretreatment and lip repositioning surgery, Botox injections maybe a useful adjunct in improving and stabilizing the results of achieved, by paralyzing the muscles during the healing period.
There are no studies, to the investigator's knowledge, exploring the use of botox combined with lip repositioning to decrease muscle pull and therefore decrease the relapse.
Detailed description
Normal gingival display has been defined by as the gum exposure between the inferior border of upper lip and gingival margin of anterior central incisors when smiling. An exposure of gingiva around 0-2 mm when smiling, and 2-4 mm of the maxillary incisor edges when the lips are at the rest state are considered as acceptable. While more than 2 mm of gingival exposure when a person smiles is stated by experts as an excessive gingival display, or what is known as "Gummy Smile",which is more of a descriptive term than a diagnosed condition, and affects a notable proportion of the population, especially women who are affected more than men.
Many studies have stated the main causes of excessive gingival display, presenting the most important factors which may lead to having a gummy Smile. The study of Roe described that lip length and the upper lip mobility rate are the main contributing factors. The previous research stated that the exposure of teeth and gingiva depends on the integrated effects of a number of variables (increased muscle capacity, vertical maxillary excess, greater inter-labial gap at resting position, and the amount of over-jet and over-bite). Pausch \& Katsoulis mentioned that abnormal gingival and maxillary anterior teeth display may take place due to numerous anatomic or functional factors, either hereditary or inborn. A narrow upper lip, an irregular eruption of teeth, excessive protuberance or vertical maxillary growth, and hypermobility of the maxillary lip and elevator muscle are common reasons for a gummy Smile. In fact, several contributing factors are affecting individuals to have a gummy Smile. Sometimes one of them is presented, although in some cases more than only one cause can be seen. Correct diagnosis of the reason leads to a proper treatment plan.
Excessive gingival display can be managed by a variety of procedures. These procedures include surgical and non-surgical methods The underlying cause of excessive gingival display or gummy Smile has the main effect on the type of procedure that will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial: Parallel group, two arm, non-inferiority trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| lip repositioning technique with Botox injection. | Experimental | Drug: Botox Injectable ProductBotulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity (Binder et al., 1998). Therefore, the technique is a useful adjunct in the esthetic improvement of the smile and provides better results when combined with resective gingival surgery(Pedron \& Mangano, 2018). |
| lip repositioning technique. | Active comparator | Drug: Botox Injectable ProductLip repositioning aims to limit the retraction of elevator smile muscles. Lip repositioning results in a shallow vestibuler restricting of the muscle pull; Thereby limiting the gingival display during smiling.(Makkiah, 2017) It is a less invasive, viable substitute for patients, has fewer post-operative complications and provides a faster recovery compared to orthognathic surgery(Grover, Gupta, \& Luthra, 2014). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gummy smile more than 3mm.
- Adults >18 years.
- Non-smokers.
- Patients with healthy systemic condition
- Normal clinical crown dimensions.
Key exclusion criteria (8 listed)
- Natural dentition upper anterior
- Pregnant or lactating women.
- Patients with inflamed gingiva or gingival enlargement.
- Inflammation or infection at the site of injection.
- Patients with allergy to botulinum toxin, lactose, and albumin.
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 |
|---|---|---|
| Botox Injectable ProductAlso: XeominBotulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity | Drug | lip repositioning technique with Botox injection., lip repositioning technique. |
Primary outcome
change in amount of gingival display
Time frame: recorded at baseline, 3, 6 ,9 months and 1 year
Amount of gingival display (from the inferior border of the upper lip vermillion border to the gingival margin of the central incisor) will be assessed from clinical photographs obtained during active smile, with a mm ruler in place
1 secondary outcome
Patient satisfaction: quesionnaire
Time frame: o The level of satisfaction during the followed periods (after two weeks, after two months, after six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botox Injectable Product in people with Gingival Overgrowth, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
change in amount of gingival display (time frame: recorded at baseline, 3, 6 ,9 months and 1 year). 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 24 Jul 2019.