Gingival RecessionNCT05604391
The Effect of Free Gingival Graft on Root Closure
A study testing Free gingival graft placed apically and Free gingival graft placed coronally in people with Gingival Recession and Lack of Keratinized Gingiva, run by Berceste Guler at 1 site in Turkey (Türkiye).
Trial summary
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Lack of Keratinized Gingiva
- What is being tested?
- Free gingival graft placed apically and Free gingival graft placed coronally
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 15 Mar 2026
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-99 years old
- The patient does not have any systemic disease
- Presence of at least one tooth with gingival recession in the mandibular anterior region
- Excessive dentin sensitivity and impaired esthetics associated with recession
- Identification of the enamel-cementum boundary in the shrinkage region
- The tooth is alive and there are no irregularities, grooves, caries and restorations in the area to be treated.
- No periodontal surgical treatment in the relevant areas in the last 24 months
- Presence of adequate keratinized and attached gingiva in the donor area
Who cannot join
- Being outside the specified age range
- Any contraindication for systematic periodontal surgery
- Failure to define the enamel-cementum boundary in the withdrawal region
- Presence of caries, restoration, root concavity in the area to be treated
- Patients who smoke more than 10 cigarettes per day
- Patients who use drugs that suppress the immune system or impair recovery
- Patients using drugs that impair bleeding
- Insufficient keratinized and attached gingiva in the donor area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100
Berceste Güler
About this study
Official title: The Effect of Two Different Graft Positioning Techniques on Creeping Attachment in Free Gingival Graft Operations
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. Evaluation of the effect of the amount of creeping attachment on the root surface caused by the free gingival grafts placed coronally and apical to the mucogingival line on the gingival recession in the mandibular anterior region with keratinized gingival deficiency with gingival recession. Forty patients with gingival recession and insufficient keratinized gingival height will be randomly divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession.
Read the detailed description
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. The "creeping attachment" phenomenon draws attention in the long-term success of root closure treatment in areas with gingival recession. "Creeping attachment" is defined as the coronal movement of the gingiva in the area where free gingival graft or connective tissue is applied in the postoperative period. The mean root closure rate with the creeping attachment is approximately 1 mm and can be detected 1 to 36 days after graft surgery. In the literature, clinical studies that measured a creeping attachment value between 0.12 and 3.5 mm in a 2-year period in free gingival grafts applied to the marginal gingival level have been reported.
Systemically healthy and non-smoking patients older than 18 years of age who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology and had gingival recession in mandibular anterior teeth and keratinized gingival deficiency will be included in the study. Systemic and dental anamnesis will be taken from the patient before the operation and clinical measurements will be recorded.
Patients will be divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession. They will be written as Group I and Group II in sealed envelopes and apical and coronal positioning groups will be chosen randomly.
The operation date will be given after the patient is given oral hygiene training and 4 weeks after receiving Phase I routine periodontal treatment. The data to be obtained preoperatively and postoperatively are as follows:
Clinical measurements
- Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Gingival index (Silness\&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Attachment loss: It is the value of the distance between a tooth and the free gingiva based on the enamel-cementum boundary measured using a periodontal sonde.
- Bleeding index on probing (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
- Pocket depth: It is the vertical distance measured between a standard periodontal probe and the base of the periodontal sulcus and the gingival margin.
- Keratinized gingival height: It is the distance from the free gingival margin to the mucogingival junction line.
- Keratinized gingival thickness: It is the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
- Gingival recession depth: It is obtained by measuring the distance between the gingival margin in the midbuccal region and the enamel-cementum boundary.
- Gingival recession width: It is the mesio-distal width of the recession from the midpoint of the distance between the enamel cementum border and the gingival margin.
- Gingival phenotype: Visibility of the periodontal tube in the sulcus
- Vestibular sulcus depth: It is the distance measured from the gingival margin to the base of the sulcus.
Sample Selection: Taking the effect size of 0.08 for the significance value in the G Power analysis program as a reference to a previously presented study, 40 teeth were planned to be taken for α= 0.05 and 80% power.
Statistical Analysis method:
All analyzes will be done with SPSS software. Intra-group temporal evaluations in test and control groups will be evaluated using Pairedsample -T or Wilcoxon test according to normal distribution values. For intergroup comparisons, according to the normal distribution of data, Student-t test will be analyzed in parametric within-group evaluations and Mann Withney U test in nonparametrics. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. The significance value will be taken as 0.05. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.
- Conditions
- Gingival Recession, Lack of Keratinized Gingiva
- Being tested
- Free gingival graft placed apically, Free gingival graft placed coronally
- Keywords
- free gingival grafts, creeping attachment, root closure, gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft placed apicallyProcedure or surgery
For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing it in the apical region of the gingival recession according to the randomly selected positioning technique.
Free gingival graft placed coronallyProcedure or surgery
For free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing the coronal region of the gingival recession according to the randomly selected positioning technique.
| Study group | Role | What they receive |
|---|---|---|
| Free gingival grafts to be placed apical to the gingival recession. | Active comparator | It is the application of free gingival graft to the apical part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency. Receives: Procedure: Free gingival graft placed apically |
| Free gingival grafts to be placed coronal to the gingival recession. | Active comparator | It is the application of free gingival graft to the coronal part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency. Receives: Procedure: Free gingival graft placed coronally |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Percent closure of the gingival recession
It is calculated by dividing the pre- and post-surgical values of the exposed root surface.
Measured: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
Secondary outcomes (3)
2. Keratinized mucosa width change
It is the pre- and post-surgical variation of the distance from the free gingival margin to the mucogingival junction line.
Measured: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
3. Keratinized mucosa width thickness change
It is the pre- and post-surgical variation of the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
Measured: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
4. Vestibular sulcus depth change
It is the pre- and post-surgical variation of the distance measured from the gingival margin to the base of the sulcus.
Measured: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Jun 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Crossover
- Model description
- Method clinical trial Free gingival graft application has been a routine and successful treatment option since the 1960s. Positioning methods are applied on or apical gingival recession. The aim of this study is to evaluate the effect of two different free gingival graft positioning techniques on the creeping attachment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berceste Guler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Güler, Study director, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604391
- Sponsor's protocol ID
- 2021-02/09
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ndividual participant data can be shared if the principal investigator is contacted
Publications
Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
PubMed 6936409Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
PubMed 19722789Bell LA, Valluzzo TA, Garnick JJ, Pennel BM. The presence of "creeping attachment" in human gingiva. J Periodontol. 1978 Oct;49(10):513-7. doi: 10.1902/jop.1978.49.10.513.
PubMed 282425Matter J, Cimasoni G. Creeping attachment after free gingival grafts. J Periodontol. 1976 Oct;47(10):574-9. doi: 10.1902/jop.1976.47.10.574.
PubMed 1067400Gul SS, Zardawi FM, Sha AM, Rauf AM. Assessment of Creeping Attachment after Free Gingival Graft in Treatment of Isolated Gingival Recession. J Int Acad Periodontol. 2019 Jul 1;21(3):125-131.
PubMed 31473705
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Graft Positioning Techniques on Creeping Attachment in Free Gingival Graft Operations
- ClinicalTrials.gov ID
- NCT05604391
- Acronym / sponsor ID
- 2021-02/09
- Conditions
- Gingival Recession, Lack of Keratinized Gingiva
- Keywords
- free gingival grafts, creeping attachment, root closure, gingival recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Berceste GulerUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 3 Nov 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.
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. Evaluation of the effect of the amount of creeping attachment on the root surface caused by the free gingival grafts placed coronally and apical to the mucogingival line on the gingival recession in the mandibular anterior region with keratinized gingival deficiency with gingival recession. Forty patients with gingival recession and insufficient keratinized gingival height will be randomly divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession.
Detailed description
Free gingival graft is a mucogingival surgical technique applied to increase keratinized gingival width and reduce gingival recession. Free gingival graft is one of the most widely used approaches in root closure treatments and in increasing the height of the keratinized gingiva. The "creeping attachment" phenomenon draws attention in the long-term success of root closure treatment in areas with gingival recession. "Creeping attachment" is defined as the coronal movement of the gingiva in the area where free gingival graft or connective tissue is applied in the postoperative period. The mean root closure rate with the creeping attachment is approximately 1 mm and can be detected 1 to 36 days after graft surgery. In the literature, clinical studies that measured a creeping attachment value between 0.12 and 3.5 mm in a 2-year period in free gingival grafts applied to the marginal gingival level have been reported.
Systemically healthy and non-smoking patients older than 18 years of age who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology and had gingival recession in mandibular anterior teeth and keratinized gingival deficiency will be included in the study. Systemic and dental anamnesis will be taken from the patient before the operation and clinical measurements will be recorded.
Patients will be divided into 2 main groups as free gingival grafts to be placed coronal and apical to the gingival recession. They will be written as Group I and Group II in sealed envelopes and apical and coronal positioning groups will be chosen randomly.
The operation date will be given after the patient is given oral hygiene training and 4 weeks after receiving Phase I routine periodontal treatment. The data to be obtained preoperatively and postoperatively are as follows:
Clinical measurements
- Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Gingival index (Silness\&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Attachment loss: It is the value of the distance between a tooth and the free gingiva based on the enamel-cementum boundary measured using a periodontal sonde.
- Bleeding index on probing (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
- Pocket depth: It is the vertical distance measured between a standard periodontal probe and the base of the periodontal sulcus and the gingival margin.
- Keratinized gingival height: It is the distance from the free gingival margin to the mucogingival junction line.
- Keratinized gingival thickness: It is the distance measured between the gingival surface and hard tissue with a standard periodontal probe inserted perpendicular to the keratinized gingiva.
- Gingival recession depth: It is obtained by measuring the distance between the gingival margin in the midbuccal region and the enamel-cementum boundary.
- Gingival recession width: It is the mesio-distal width of the recession from the midpoint of the distance between the enamel cementum border and the gingival margin.
- Gingival phenotype: Visibility of the periodontal tube in the sulcus
- Vestibular sulcus depth: It is the distance measured from the gingival margin to the base of the sulcus.
Sample Selection: Taking the effect size of 0.08 for the significance value in the G Power analysis program as a reference to a previously presented study, 40 teeth were planned to be taken for α= 0.05 and 80% power.
Statistical Analysis method:
All analyzes will be done with SPSS software. Intra-group temporal evaluations in test and control groups will be evaluated using Pairedsample -T or Wilcoxon test according to normal distribution values. For intergroup comparisons, according to the normal distribution of data, Student-t test will be analyzed in parametric within-group evaluations and Mann Withney U test in nonparametrics. The normal distribution of the data will be evaluated with the Kolmogorov-Smirnov test. The significance value will be taken as 0.05. Relationships between variables will be evaluated with Logistic Regression Analysis or Multivariate Regression Analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Method clinical trial Free gingival graft application has been a routine and successful treatment option since the 1960s. Positioning methods are applied on or apical gingival recession. The aim of this study is to evaluate the effect of two different free gingival graft positioning techniques on the creeping attachment.
| Arm | Type | Receives |
|---|---|---|
| Free gingival grafts to be placed apical to the gingival recession. | Active comparator | Procedure: Free gingival graft placed apicallyIt is the application of free gingival graft to the apical part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency. |
| Free gingival grafts to be placed coronal to the gingival recession. | Active comparator | Procedure: Free gingival graft placed coronallyIt is the application of free gingival graft to the coronal part of the recession area of mandibular anterior teeth with gingival recession and keratinized gingival height deficiency. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-99 years old
- The patient does not have any systemic disease
- Presence of at least one tooth with gingival recession in the mandibular anterior region
- Excessive dentin sensitivity and impaired esthetics associated with recession
- Identification of the enamel-cementum boundary in the shrinkage region
Key exclusion criteria (8 listed)
- Being outside the specified age range
- Any contraindication for systematic periodontal surgery
- Failure to define the enamel-cementum boundary in the withdrawal region
- Presence of caries, restoration, root concavity in the area to be treated
- Patients who smoke more than 10 cigarettes per day
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 |
|---|---|---|
| Free gingival graft placed apicallyFor free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing it in the apical region of the gingival recession according to the randomly selected positioning technique. | Procedure or surgery | Free gingival grafts to be placed apical to the gingival recession. |
| Free gingival graft placed coronallyFor free gingival graft operation, the recipient area will be prepared with a half-thickness flap. A graft with a thickness of approximately 1.5 mm and a width and height of the recipient bed will be obtained from the palatal region in accordance with the recipient bed, and it will be sutured by placing the coronal region of the gingival recession according to the randomly selected positioning technique. | Procedure or surgery | Free gingival grafts to be placed coronal to the gingival recession. |
Primary outcome
1. Percent closure of the gingival recession
Time frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
It is calculated by dividing the pre- and post-surgical values of the exposed root surface.
3 secondary outcomes
2. Keratinized mucosa width change
Time frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
3. Keratinized mucosa width thickness change
Time frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
4. Vestibular sulcus depth change
Time frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month
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 10 Mar 2025.
- Background: PubMed 6936409Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
- Background: PubMed 19722789Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
- Background: PubMed 282425Bell LA, Valluzzo TA, Garnick JJ, Pennel BM. The presence of "creeping attachment" in human gingiva. J Periodontol. 1978 Oct;49(10):513-7. doi: 10.1902/jop.1978.49.10.513.
- Background: PubMed 1067400Matter J, Cimasoni G. Creeping attachment after free gingival grafts. J Periodontol. 1976 Oct;47(10):574-9. doi: 10.1902/jop.1976.47.10.574.
- Background: PubMed 31473705Gul SS, Zardawi FM, Sha AM, Rauf AM. Assessment of Creeping Attachment after Free Gingival Graft in Treatment of Isolated Gingival Recession. J Int Acad Periodontol. 2019 Jul 1;21(3):125-131.
- Individual participant dataSharing planned: Yes. ndividual participant data can be shared if the principal investigator is contacted
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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.
Berceste Güler study director
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft placed apically and Free gingival graft placed coronally in people with Gingival Recession and Lack of Keratinized Gingiva, run by Berceste Guler at 1 site in Turkey (Türkiye).
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 8 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. 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 Turkey (Türkiye). 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 Berceste Güler (+05059359207, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Percent closure of the gingival recession (time frame: Postoperatively 1th month, Postoperatively 3th month, Postoperatively 6th month, Postoperatively 12th month). 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 NCT05604391, which also lists 5 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 10 Mar 2025.