Cervical LesionNCT05593159
Bioactive Restorative Material in Non-Carious Cervical Lesions
A study testing Dentin Conditioning, RM-GIC and 1-step adhesive in people with Cervical Lesion, run by Damascus University at 1 site in Syria.
Trial summary
Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Lesion
- What is being tested?
- Dentin Conditioning, RM-GIC and 1-step adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 15 May 2022to 1 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health
- with at least 20 teeth under occlusion
- Should have three or more NCCLs which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility
Who cannot join
- Poor oral hygiene
- Severe periodontitis
- Severe bruxism habits
- Xerostomia
Trial locations and contacts
1 site in 1 country.
Syria1 site
Restorative Dentistry, Faculty of Dental Medicine, Damascus University
Damascus
About this study
Official title: Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions
Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.
Read the detailed description
Cention N is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. The manufacturing company recommends using Cention N with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations.
This study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to RM-GIC (Fuji II LC).
Information about oral and tooth brushing habits along with detailed information about the characteristics of each NCCL, gingival status, and preoperative sensitivity will be collected for each patient.
- Conditions
- Cervical Lesion
- Being tested
- Dentin Conditioning, RM-GIC, 1-step adhesive, Cention N, Dentin roughness
- Keywords
- Non-carious cervical lesions (NCCLs), Composite restorations, Bioactive Restorative Material (Cention N), Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dentin ConditioningOther
After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried
RM-GICOther
RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterword light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
1-step adhesiveOther
A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2).
Cention NOther
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
Dentin roughnessOther
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Gingival retentive groove preparationOther
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
| Study group | Role | What they receive |
|---|---|---|
| Dentin Conditioning & RM-GIC | Active comparator | Dentin Conditioning:
After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried.
RM-GIC:
RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterward light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity. Receives: Other: Dentin Conditioning; Other: RM-GIC |
| 1-step adhesive & Cention N | Experimental | 1-step adhesive: A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2).
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) Receives: Other: 1-step adhesive; Other: Cention N |
| Dentin roughness & Gingival retentive groove preparation & Cention N | Experimental | Dentin roughness:
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Gingival retentive groove preparation:
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Cention N:
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) Receives: Other: Cention N; Other: Dentin roughness; Other: Gingival retentive groove preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retention rate
Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Secondary outcomes (9)
Change in marginal adaptation
Rated by modified USPHS. Alpha: Restoration is continuous with existing anatomic form. Bravo: Detectable V-shaped defect in enamel only. Catches explorer going both ways. Charlie: Detectable V-shaped defect to dentin-enamel junction.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in restoration fracture
Rated by modified USPHS. Alpha: None. Bravo: Small chip, but Clinically acceptable. Charlie: Failure due to bulk restorative fracture.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in marginal discoloration
Rated by modified USPHS. Alpha: No discoloration along the margin. Bravo: Slight and superficial staining (removable, usually localized). Charlie: Deep staining cannot be polished away.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in anatomic form
Rated by modified USPHS. Alpha: Appropriate contour. Bravo: Slightly over/under contoured. Charlie: Unacceptably over/under contoured
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in surface texture
Rated by modified USPHS. Alpha: Enamel-like surface. Bravo: Surface rougher than enamel (clinically acceptable). Charlie: Surface unacceptably rough.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in secondary caries
Rated by modified USPHS. Alpha: No evidence of caries contiguous with the margin. Charlie: Evidence of presence of caries.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity with stimulation
Rated by Modified visual analog scale (VAS).
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity without stimulation
Rated by Modified visual analog scale (VAS).
Measured: Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year
Change in patient satisfaction
Rated by modified USPHS. Alpha: Patient is totally satisfied. Bravo: Patient has esthetic complains, or complains related to the inability to chew comfortably. Charlie: Patient is completely unsatisfied.
Measured: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start15 May 2022
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical LesionStudies 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
- Split mouth design; each patient will receive three restorations, one for each arm of this study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hussam Milly, PhD, Study director, Milly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593159
- Sponsor's protocol ID
- UDDS-OperativeDent-02-2023
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezerra IM, Brito ACM, de Sousa SA, Santiago BM, Cavalcanti YW, de Almeida LFD. Glass ionomer cements compared with composite resin in restoration of noncarious cervical lesions: A systematic review and meta-analysis. Heliyon. 2020 May 21;6(5):e03969. doi: 10.1016/j.heliyon.2020.e03969. eCollection 2020 May.
PubMed 32462087Francois P, Fouquet V, Attal JP, Dursun E. Commercially Available Fluoride-Releasing Restorative Materials: A Review and a Proposal for Classification. Materials (Basel). 2020 May 18;13(10):2313. doi: 10.3390/ma13102313.
PubMed 32443424Francois P, Remadi A, Le Goff S, Abdel-Gawad S, Attal JP, Dursun E. Flexural properties and dentin adhesion in recently developed self-adhesive bulk-fill materials. J Oral Sci. 2021 Mar 31;63(2):139-144. doi: 10.2334/josnusd.20-0448. Epub 2021 Feb 17.
PubMed 33597335Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.
PubMed 19830963Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Munoz MA. Effect of dentin roughness on the adhesive performance in non-carious cervical lesions: A double-blind randomized clinical trial. J Dent. 2018 Feb;69:60-69. doi: 10.1016/j.jdent.2017.09.011. Epub 2017 Sep 27.
PubMed 28962842Panpisut P, Toneluck A. Monomer conversion, dimensional stability, biaxial flexural strength, and fluoride release of resin-based restorative material containing alkaline fillers. Dent Mater J. 2020 Aug 2;39(4):608-615. doi: 10.4012/dmj.2019-020. Epub 2020 Feb 7.
PubMed 32037385Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.
PubMed 11137632Vallittu PK, Boccaccini AR, Hupa L, Watts DC. Bioactive dental materials-Do they exist and what does bioactivity mean? Dent Mater. 2018 May;34(5):693-694. doi: 10.1016/j.dental.2018.03.001. Epub 2018 Mar 20. No abstract available.
PubMed 29571660Mustafa K, Alfakhry G, Milly H. Periodontal Evaluation for a New Alkasite Restorative Material in Noncarious Cervical Lesions: A Randomized-Controlled Clinical Trial. Clin Exp Dent Res. 2024 Dec;10(6):e70025. doi: 10.1002/cre2.70025.
PubMed 39400529
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT05593159
- Acronym / sponsor ID
- UDDS-OperativeDent-02-2023
- Conditions
- Cervical Lesion
- Keywords
- Non-carious cervical lesions (NCCLs), Composite restorations, Bioactive Restorative Material (Cention N), Adhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Oct 2022 (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.
Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.
Detailed description
Cention N is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. The manufacturing company recommends using Cention N with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations.
This study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to RM-GIC (Fuji II LC).
Information about oral and tooth brushing habits along with detailed information about the characteristics of each NCCL, gingival status, and preoperative sensitivity will be collected for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Split mouth design; each patient will receive three restorations, one for each arm of this study.
| Arm | Type | Receives |
|---|---|---|
| Dentin Conditioning & RM-GIC | Active comparator | Other: Dentin Conditioning, Other: RM-GICDentin Conditioning: After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried. RM-GIC: RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterward light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity. |
| 1-step adhesive & Cention N | Experimental | Other: 1-step adhesive, Other: Cention N1-step adhesive: A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2). Cention N: The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) |
| Dentin roughness & Gingival retentive groove preparation & Cention N | Experimental | Other: Cention N, Other: Dentin roughness, Other: Gingival retentive groove preparationDentin roughness: Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made) Gingival retentive groove preparation: Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. Cention N: The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good general health
- with at least 20 teeth under occlusion
- Should have three or more NCCLs which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility
Key exclusion criteria (4 listed)
- Poor oral hygiene
- Severe periodontitis
- Severe bruxism habits
- Xerostomia
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 |
|---|---|---|
| Dentin ConditioningAfter washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried | Other | Dentin Conditioning & RM-GIC |
| RM-GICRM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterword light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity. | Other | Dentin Conditioning & RM-GIC |
| 1-step adhesiveA universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2). | Other | 1-step adhesive & Cention N |
| Cention NThe cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) | Other | 1-step adhesive & Cention N, Dentin roughness & Gingival retentive groove preparation & Cention N |
| Dentin roughnessUsing a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made) | Other | Dentin roughness & Gingival retentive groove preparation & Cention N |
| Gingival retentive groove preparationUsing size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. | Other | Dentin roughness & Gingival retentive groove preparation & Cention N |
Primary outcome
Change in retention rate
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing.
9 secondary outcomes
Change in marginal adaptation
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in restoration fracture
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in marginal discoloration
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in anatomic form
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in surface texture
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in secondary caries
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity with stimulation
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity without stimulation
Time frame: Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year
Change in patient satisfaction
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
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 Feb 2024.
- Results publication: PubMed 32462087Bezerra IM, Brito ACM, de Sousa SA, Santiago BM, Cavalcanti YW, de Almeida LFD. Glass ionomer cements compared with composite resin in restoration of noncarious cervical lesions: A systematic review and meta-analysis. Heliyon. 2020 May 21;6(5):e03969. doi: 10.1016/j.heliyon.2020.e03969. eCollection 2020 May.
- Results publication: PubMed 32443424Francois P, Fouquet V, Attal JP, Dursun E. Commercially Available Fluoride-Releasing Restorative Materials: A Review and a Proposal for Classification. Materials (Basel). 2020 May 18;13(10):2313. doi: 10.3390/ma13102313.
- Results publication: PubMed 33597335Francois P, Remadi A, Le Goff S, Abdel-Gawad S, Attal JP, Dursun E. Flexural properties and dentin adhesion in recently developed self-adhesive bulk-fill materials. J Oral Sci. 2021 Mar 31;63(2):139-144. doi: 10.2334/josnusd.20-0448. Epub 2021 Feb 17.
- Results publication: PubMed 19830963Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.
- Results publication: PubMed 28962842Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Munoz MA. Effect of dentin roughness on the adhesive performance in non-carious cervical lesions: A double-blind randomized clinical trial. J Dent. 2018 Feb;69:60-69. doi: 10.1016/j.jdent.2017.09.011. Epub 2017 Sep 27.
- Results publication: PubMed 32037385Panpisut P, Toneluck A. Monomer conversion, dimensional stability, biaxial flexural strength, and fluoride release of resin-based restorative material containing alkaline fillers. Dent Mater J. 2020 Aug 2;39(4):608-615. doi: 10.4012/dmj.2019-020. Epub 2020 Feb 7.
- Results publication: PubMed 11137632Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.
- Results publication: PubMed 29571660Vallittu PK, Boccaccini AR, Hupa L, Watts DC. Bioactive dental materials-Do they exist and what does bioactivity mean? Dent Mater. 2018 May;34(5):693-694. doi: 10.1016/j.dental.2018.03.001. Epub 2018 Mar 20. No abstract available.
- Derived from this study: PubMed 39400529Mustafa K, Alfakhry G, Milly H. Periodontal Evaluation for a New Alkasite Restorative Material in Noncarious Cervical Lesions: A Randomized-Controlled Clinical Trial. Clin Exp Dent Res. 2024 Dec;10(6):e70025. doi: 10.1002/cre2.70025.
- Individual participant dataSharing planned: No
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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.
Hussam Milly, PhD study director
Milly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dentin Conditioning, RM-GIC and 1-step adhesive in people with Cervical Lesion, run by Damascus University at 1 site in Syria.
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 Feb 2024. 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 Syria. 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?
Change in retention rate (time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year). 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 NCT05593159, which also lists 9 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 28 Feb 2024.