Oral UlcerPhase 4NCT03633292
Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
A Phase 4 study testing Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) and Master formula of aloe vera gel 80% in people with Oral Ulcer, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Ulcer
- What is being tested?
- Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) and Master formula of aloe vera gel 80%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Jan 2018
- Phase
- Phase 4
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who have just begun orthodontic treatment after bracket cementation.
- Be willing and have signed the informed consent.
- Presence of cemented metal brackets throughout the upper and lower arches.
- Presence of good oral health: dental, periodontal and soft tissue
Who cannot join
- Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.
- Pregnant, since they are not claimants of fixed multibrackets appliances.
- Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.
- Under 11 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial
The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.
The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.
The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.
- Conditions
- Oral Ulcer
- Being tested
- Antiseptic clorhexidine gel (Lacer, Barcelona, Spain), Master formula of aloe vera gel 80%
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)Drug
Together with the dispensing container, the dosing and dosage of the gel in research will be attached, with the description of the pharmaceutical form, packaging and labeling of the product. Packages with 8 ml of the gel under investigation, sufficient treatment for 1 month of applications. Posology: After tooth brushing, apply a small amount of gel on the fingertip of a freshly washed finger and spread it over the gum, doing a gentle massage, for 15 ", 2 times a day after proper oral hygiene and it is recommended not to ingest no liquid or food until after half an hour of use.
Master formula of aloe vera gel 80%Drug
Blindly and in the same container as chlorhexidine, patients will be instructed to apply aloe vera gel on the gums and mucous membranes once the orthodontic appliances have been cemented
| Study group | Role | What they receive |
|---|---|---|
| Clorhexidine | Active comparator | - Clorhexidine Gel (LACER®, Barcelona, Spain) 0.12%, application 2 times / days for 1 month. The gel will be applied two times/day each 12 hours to the gingiva and mucosa. Receives: Drug: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) |
| Aloe Vera | Experimental | - 80% Aloe vera gel, application 2 times / day for 1 month
Master formula of 80% aloe vera gel Aloe Vera extract, obtained from the central part of the caudal leaves of plants with more than 8 years of life, eliminating its bark. Formulated with carbopol, hydrophilic crosslinked polymer of acrylic acid and vitamin C. The mixture is presented in containers that serve as a container for preparation and will be dispensed in the canister format with applicator tube. Receives: Drug: Master formula of aloe vera gel 80% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of traumatic oral ulcers
The patient will attend his scheduled appointment for bracket cementation. Before cementing, we will complete the clinical history (frequency of brushing, smoker or non-smoker, age, sex) aided by intraoral photographs, always collected in the same order according to protocol and by the same researcher. After the cementation, the patient will be included in the study in a random way in the corresponding group. One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of friction or traumatic ulcers will be evaluated.
Measured: 30 days
Secondary outcomes (2)
Prevalence of gingival inflammation
One month after cementing and coinciding with the periodic visit of the patient, the presence / absence gingival inflammation through the gingival inflammation index will be evaluated.
0 = Normal gingiva, absence of inflammation, no change in color, no bleeding.
1 = slight inflammation, slight change in color, small alteration of the surface, no hemorrhage. 2 = Moderate inflammation, redness, edema and hemorrhage on probing and pressure. 3 = Strong inflammation, intense redness, edema, tendency to hemorrhages, eventually ulceration. It is interpreted as follows: Sum of the degree of each face / No. of faces observed 0.0-1.0 = incipient gingivitis 1.1-2.0 = Moderate gingivitis 2,1-3,0 = Severe gingivitis
Measured: 30 days
Prevalence of gingival bleeding
One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of gingival bleeding through the gingival index or Simplified haemorrhage index (DHI). It is taken on four sides of the tooth, distal, vestibular, mesial and palatal. The average of the four measurements will be the value of that patient. Periodontal probe will be used. 0 = absence of hemorrhage; 1 = presence of haemorrhage.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study startJan 2015
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral UlcerStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Alfonso X El Sabio University
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633292
- Sponsor's protocol ID
- RCT-04-16
- Status last verified
- Aug 2018
- First submitted
- 25 Jun 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03633292
- Acronym / sponsor ID
- RCT-04-16
- Conditions
- Oral Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Alfonso X El Sabio University
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Aug 2018 (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 development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.
The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.
The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clorhexidine | Active comparator | Drug: Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)- Clorhexidine Gel (LACER®, Barcelona, Spain) 0.12%, application 2 times / days for 1 month. The gel will be applied two times/day each 12 hours to the gingiva and mucosa. |
| Aloe Vera | Experimental | Drug: Master formula of aloe vera gel 80%- 80% Aloe vera gel, application 2 times / day for 1 month Master formula of 80% aloe vera gel Aloe Vera extract, obtained from the central part of the caudal leaves of plants with more than 8 years of life, eliminating its bark. Formulated with carbopol, hydrophilic crosslinked polymer of acrylic acid and vitamin C. The mixture is presented in containers that serve as a container for preparation and will be dispensed in the canister format with applicator tube. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have just begun orthodontic treatment after bracket cementation.
- Be willing and have signed the informed consent.
- Presence of cemented metal brackets throughout the upper and lower arches.
- Presence of good oral health: dental, periodontal and soft tissue
Key exclusion criteria (4 listed)
- Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.
- Pregnant, since they are not claimants of fixed multibrackets appliances.
- Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.
- Under 11 years old.
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 |
|---|---|---|
| Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)Together with the dispensing container, the dosing and dosage of the gel in research will be attached, with the description of the pharmaceutical form, packaging and labeling of the product. Packages with 8 ml of the gel under investigation, sufficient treatment for 1 month of applications. Posology: After tooth brushing, apply a small amount of gel on the fingertip of a freshly washed finger and spread it over the gum, doing a gentle massage, for 15 ", 2 times a day after proper oral hygiene and it is recommended not to ingest no liquid or food until after half an hour of use. | Drug | Clorhexidine |
| Master formula of aloe vera gel 80%Blindly and in the same container as chlorhexidine, patients will be instructed to apply aloe vera gel on the gums and mucous membranes once the orthodontic appliances have been cemented | Drug | Aloe Vera |
Primary outcome
Prevalence of traumatic oral ulcers
Time frame: 30 days
The patient will attend his scheduled appointment for bracket cementation. Before cementing, we will complete the clinical history (frequency of brushing, smoker or non-smoker, age, sex) aided by intraoral photographs, always collected in the same order according to protocol and by the same researcher. After the cementation, the patient will be included in the study in a random way in the corresponding group. One month after cementing and coinciding with the periodic visit of the patient, the presence / absence of friction or traumatic ulcers will be evaluated.
2 secondary outcomes
Prevalence of gingival inflammation
Time frame: 30 days
Prevalence of gingival bleeding
Time frame: 30 days
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 16 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Ulcer
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Not yet recruitingPhase 1
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
Psoriasis, Arthritis, Psoriatic
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiseptic clorhexidine gel (Lacer, Barcelona, Spain) and Master formula of aloe vera gel 80% in people with Oral Ulcer, run by University of Santiago de Compostela at 1 site in Spain.
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 4 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 16 Aug 2018. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of traumatic oral ulcers (time frame: 30 days). 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 16 Aug 2018.