PeriodontitisPhase 4NCT05834517
''Efficacy of Locally Delivered Hyaluronic Acid Gel as an Adjunctive to Non-Surgical Management of Periodontitis
A Phase 4 study testing Hyaluronic acid and non surgical periodontal therapy in people with Periodontitis, run by Ehab Haider Hassan El-emam at 1 site in Egypt.
Trial summary
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Hyaluronic acid and non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2022to 10 Dec 2022
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- .Patients have to be free from any systemic disease as proven by Burket's oral medicine health history questionnaire (Glik et al., 2008).
- .Both genders aged 20-55.
- . Periodontitis (Stage II or stage III) Patients; (3-6 mm CAL ,pocket depth ≤7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis) (Tonetti et al., 2017).
Who cannot join
- Pregnant lactating females
- Smoking
- Patients who can't be committed to oral hygiene instructions
- History of periodontal surgery or antimicrobial therapy for at least 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ''Efficacy of Locally Delivered Hyaluronic Acid Gel as an Adjunctive to Non-Surgical Management of Stage II or Stage III Periodontitis
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013).
Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997).
There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).
Read the detailed description
Periodontitis is a chronic multifactorial inflammatory disease, associated with the dental plaque biofilms, its distinct feature is destruction of the tooth supporting apparatus. Its main features include: damage of the periodontal tissue, that's manifested by clinical attachment loss, alveolar bone loss, periodontal pocketing and bleeding gum (Armitage, 1999).
A new periodontitis classification scheme has been approved, in which forms of the disease previously known as "chronic" or "aggressive" are now gathered under a single term ("periodontitis") and are more characterized based on a multi-dimensional staging and grading system. Staging is basically reliant on the severity of disease as well as on the difficulty of disease management, on the other hand , grading offers additional information about biological aspects of the disease including a history-based analysis of the rate of periodontitis progression; risk assessment for further progression and analysis of likely poor outcomes of treatment (Caton et al., 2018; Papapanou et al., 2018).
Host-Microbial interaction is having a huge effect on the nature of periodontal disease progression. The microbial biofilm elicits the host to release inflammatory mediators that have a negative effect on the connective tissues. The biofilm or dental plaque is required but not enough to induce periodontitis, since it is the host inflammatory response to this microbial challenge that eventually can be the reason for destruction of the periodontium (Haffajee and Socransky, 1994; Page , 1997; Darveau, 2010).
Physical removal of dental plaque through debridement and/or using antimicrobial agents is the most prevalent management of periodontitis. Initially, scaling and root planing (SRP) is done with the means of hand or ultrasonic instruments to debride the root surface, allowing the development of a long junctional epithelium. Clinically, in case of lack of accessibility like extensive tissue loss, deep periodontal pocket and furcation involvement make it unclear to determine the efficacy of the debridement (Lindhe, 1985).
The use systemic antibiotics (ABs) can contribute in treatment goals without surgical treatment. However, their usage is limited to particular patients for those who have previously two courses of SRP with no improvement in periodontal pocket depth. Additionally, the side effects and rise in AB resistance over time have reduced the number of cases managed in this way (Walters et al., 2015).
Local antimicrobial therapy includes the direct placement of an antimicrobial agent into sub gingival sites, limiting the effect of the agent on non-oral body sites. The main goal in using an intra-pocket device for the delivery of an antibacterial agent is maintenance of therapeutic levels of the drug for the required period of time. This method has direct influence on the pathogens, without any damage to the tissues (Garg, 2015).
The first local drug delivery system in periodontal treatment was ActiciteTM. The first non resorbable system. Although quite effective, the delivery of this system in the periodontal pockets required extra skills and another visit to the dentist in order to be removed. The drawbacks of the non-resorbable systems headed to the advance of resorbable systems for antimicrobial delivery like ATRIDOXTM, gel containing 10 % doxycyline hyclate. Progresses in the formulation of local delivery systems lead to the manufacture of ARESTINTM, sustained release product consist of minocycline (Krayer et al., 2010).
Local delivery antibiotics that are commercially available as controlled release devices had many disadvantages including limited spectrum of antimicrobial activity in some periodontal polymicrobial infections, risk of generating antimicrobial resistance and massive acquisition cost (Sltos , 2002).
The most extensive used and studied antiseptic in oral diseases is chlorhexidine. Chlorhexidine displays high affinity towards bacteria .The highest advantages of chlorhexidine application after SRP or surgical periodontal treatment include better-quality in wound healing and general plaque control (Horz \& Conrads, 2007). However, even with the advantages, the application may end with staining of the teeth, taste disturbances and increase of calculus formation (Zanatta et al., 2010).
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013).
Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997).
There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).
The anti-inflammatory action of hyaluronic acid is related to the role of exogenous Hyaluronan as a scavenger by draining metaloprotinases, prostaglandins and other bio-active molecules (Laurant et al., 1995). Moreover, hyaluronic acid is anti-edematous due to its osmotic activity. The high concentration of medium and lower molecular weight hyaluronic acid has a possible bacteriostatic role especially on aggregatibacter actinomyecetemcomitans and staph aureus strains which are usually found in periodontal wounds (Pirnazar et al., 1999).
In patients with chronic periodontitis, the adjunctive application of hyaluronic acid to non -surgical periodontal treatment including (scaling and root planning) results in much higher clinical improvement including probing depth and bleeding on probing (Bertl, 2015).
A clinical trial by (Yi Xu et al ., 2004) used HA gel as an adjunctive to scaling and root planning in treatment of chronic periodontitis , regarding the clinical parameters and microbiological analysis had revealed that HA gel has an essential role in improvement of all clinical parameters but in contrary, microbiological analysis using conventional PCR revealed that hyaluronic acid has no effect on the bacteria .
Based on the previously mentioned properties hyaluronic acid, We hypothesized that hyaluronic acid has a major role to be used as an adjunctive to non-surgical treatment in periodontitis patients.
- Conditions
- Periodontitis
- Being tested
- Hyaluronic acid, non surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Also called hyaluronan
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts
non surgical periodontal therapyProcedure or surgery
NSPT, with or without adjunctive therapies, is an effective treatment for periodontitis. It reduces PD and results in formation of some new attachment; however, it also has several limitations, and surgical therapy might be required to control inflammation and optimize outcomes. When used for non-surgical scaling and root planing, periodontal curettes can reach a mean PD of up to approximately 5.5 mm. The mean PD in which a plaque-free and calculus-free surface can be established is <4 mm
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid/ scaling | Experimental | topical application of hyaluronic acid after scaling by 1 day Receives: Drug: Hyaluronic acid; Procedure: non surgical periodontal therapy |
| scaling | Experimental | scaling only Receives: Procedure: non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score
1-Plaque index (PI) 2. Sulcus bleeding index (BI) 3-Probing depth (PD) 4-Clinical attachment loss level (CAL)
Measured: 3 months
Secondary outcomes (1)
analyzing quantitative changes of pathogenic periodontal bacteria as a secondary objectives.
using real time PCR for analyzing the bacterial loads of 1. Porphyromonus gingivalis 2. Aggregatibacter Actinomycetumomitans
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start2 May 2022
- Primary completion5 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- topical application of hyaluronic acid in patients with periodontitis 1 day after scaling
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ehab Haider Hassan El-emam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ehab Haider Hassan El-emam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834517
- Sponsor's protocol ID
- FDASU-RECD125091
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''Efficacy of Locally Delivered Hyaluronic Acid Gel as an Adjunctive to Non-Surgical Management of Stage II or Stage III Periodontitis
- ClinicalTrials.gov ID
- NCT05834517
- Acronym / sponsor ID
- FDASU-RECD125091
- Conditions
- Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ehab Haider Hassan El-emamUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 28 Apr 2023 (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.
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013).
Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997).
There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).
Detailed description
Periodontitis is a chronic multifactorial inflammatory disease, associated with the dental plaque biofilms, its distinct feature is destruction of the tooth supporting apparatus. Its main features include: damage of the periodontal tissue, that's manifested by clinical attachment loss, alveolar bone loss, periodontal pocketing and bleeding gum (Armitage, 1999).
A new periodontitis classification scheme has been approved, in which forms of the disease previously known as "chronic" or "aggressive" are now gathered under a single term ("periodontitis") and are more characterized based on a multi-dimensional staging and grading system. Staging is basically reliant on the severity of disease as well as on the difficulty of disease management, on the other hand , grading offers additional information about biological aspects of the disease including a history-based analysis of the rate of periodontitis progression; risk assessment for further progression and analysis of likely poor outcomes of treatment (Caton et al., 2018; Papapanou et al., 2018).
Host-Microbial interaction is having a huge effect on the nature of periodontal disease progression. The microbial biofilm elicits the host to release inflammatory mediators that have a negative effect on the connective tissues. The biofilm or dental plaque is required but not enough to induce periodontitis, since it is the host inflammatory response to this microbial challenge that eventually can be the reason for destruction of the periodontium (Haffajee and Socransky, 1994; Page , 1997; Darveau, 2010).
Physical removal of dental plaque through debridement and/or using antimicrobial agents is the most prevalent management of periodontitis. Initially, scaling and root planing (SRP) is done with the means of hand or ultrasonic instruments to debride the root surface, allowing the development of a long junctional epithelium. Clinically, in case of lack of accessibility like extensive tissue loss, deep periodontal pocket and furcation involvement make it unclear to determine the efficacy of the debridement (Lindhe, 1985).
The use systemic antibiotics (ABs) can contribute in treatment goals without surgical treatment. However, their usage is limited to particular patients for those who have previously two courses of SRP with no improvement in periodontal pocket depth. Additionally, the side effects and rise in AB resistance over time have reduced the number of cases managed in this way (Walters et al., 2015).
Local antimicrobial therapy includes the direct placement of an antimicrobial agent into sub gingival sites, limiting the effect of the agent on non-oral body sites. The main goal in using an intra-pocket device for the delivery of an antibacterial agent is maintenance of therapeutic levels of the drug for the required period of time. This method has direct influence on the pathogens, without any damage to the tissues (Garg, 2015).
The first local drug delivery system in periodontal treatment was ActiciteTM. The first non resorbable system. Although quite effective, the delivery of this system in the periodontal pockets required extra skills and another visit to the dentist in order to be removed. The drawbacks of the non-resorbable systems headed to the advance of resorbable systems for antimicrobial delivery like ATRIDOXTM, gel containing 10 % doxycyline hyclate. Progresses in the formulation of local delivery systems lead to the manufacture of ARESTINTM, sustained release product consist of minocycline (Krayer et al., 2010).
Local delivery antibiotics that are commercially available as controlled release devices had many disadvantages including limited spectrum of antimicrobial activity in some periodontal polymicrobial infections, risk of generating antimicrobial resistance and massive acquisition cost (Sltos , 2002).
The most extensive used and studied antiseptic in oral diseases is chlorhexidine. Chlorhexidine displays high affinity towards bacteria .The highest advantages of chlorhexidine application after SRP or surgical periodontal treatment include better-quality in wound healing and general plaque control (Horz \& Conrads, 2007). However, even with the advantages, the application may end with staining of the teeth, taste disturbances and increase of calculus formation (Zanatta et al., 2010).
Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013).
Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997).
There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).
The anti-inflammatory action of hyaluronic acid is related to the role of exogenous Hyaluronan as a scavenger by draining metaloprotinases, prostaglandins and other bio-active molecules (Laurant et al., 1995). Moreover, hyaluronic acid is anti-edematous due to its osmotic activity. The high concentration of medium and lower molecular weight hyaluronic acid has a possible bacteriostatic role especially on aggregatibacter actinomyecetemcomitans and staph aureus strains which are usually found in periodontal wounds (Pirnazar et al., 1999).
In patients with chronic periodontitis, the adjunctive application of hyaluronic acid to non -surgical periodontal treatment including (scaling and root planning) results in much higher clinical improvement including probing depth and bleeding on probing (Bertl, 2015).
A clinical trial by (Yi Xu et al ., 2004) used HA gel as an adjunctive to scaling and root planning in treatment of chronic periodontitis , regarding the clinical parameters and microbiological analysis had revealed that HA gel has an essential role in improvement of all clinical parameters but in contrary, microbiological analysis using conventional PCR revealed that hyaluronic acid has no effect on the bacteria .
Based on the previously mentioned properties hyaluronic acid, We hypothesized that hyaluronic acid has a major role to be used as an adjunctive to non-surgical treatment in periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- topical application of hyaluronic acid in patients with periodontitis 1 day after scaling
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid/ scaling | Experimental | Drug: Hyaluronic acid, Procedure: non surgical periodontal therapytopical application of hyaluronic acid after scaling by 1 day |
| scaling | Experimental | Procedure: non surgical periodontal therapyscaling only |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- .Patients have to be free from any systemic disease as proven by Burket's oral medicine health history questionnaire (Glik et al., 2008).
- .Both genders aged 20-55.
- . Periodontitis (Stage II or stage III) Patients; (3-6 mm CAL ,pocket depth ≤7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis) (Tonetti et al., 2017).
Key exclusion criteria (4 listed)
- Pregnant lactating females
- Smoking
- Patients who can't be committed to oral hygiene instructions
- History of periodontal surgery or antimicrobial therapy for at least 4 months.
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 |
|---|---|---|
| Hyaluronic acidAlso: hyaluronanHyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts | Drug | hyaluronic acid/ scaling |
| non surgical periodontal therapyNSPT, with or without adjunctive therapies, is an effective treatment for periodontitis. It reduces PD and results in formation of some new attachment; however, it also has several limitations, and surgical therapy might be required to control inflammation and optimize outcomes. When used for non-surgical scaling and root planing, periodontal curettes can reach a mean PD of up to approximately 5.5 mm. The mean PD in which a plaque-free and calculus-free surface can be established is <4 mm | Procedure or surgery | hyaluronic acid/ scaling, scaling |
Primary outcome
clinical score
Time frame: 3 months
1-Plaque index (PI) 2. Sulcus bleeding index (BI) 3-Probing depth (PD) 4-Clinical attachment loss level (CAL)
1 secondary outcome
analyzing quantitative changes of pathogenic periodontal bacteria as a secondary objectives.
Time frame: 1 month
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 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Hyaluronic acid and non surgical periodontal therapy in people with Periodontitis, run by Ehab Haider Hassan El-emam at 1 site in Egypt.
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 3 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 28 Apr 2023. 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 Egypt. 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?
clinical score (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 Apr 2023.