Soft Tissue AtrophyNCT06039839
Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation
A study testing Closure of the donor area after CTG harvesting without the use of collagen matrix and Closure of the donor area after CTG harvesting with collagen matrix in people with Soft Tissue Atrophy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
An interventional prospective randomised clinical trial (RCT) in parallel groups is planned. The sample size was 30 patients who will be randomly divided into two groups based on the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Soft Tissue Atrophy
- What is being tested?
- Closure of the donor area after CTG harvesting without the use of collagen matrix and Closure of the donor area after CTG harvesting with collagen matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 17 Jan 2023to 15 May 2025
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of written informed consent of the patient to participate in the study;
- Age between 18 and 45 years;
- Included defects on the maxilla or mandible within 1-2 teeth combined with soft tissue thickness deficiency in the area of dental implants (< 2 mm);
- Teeth without periodontal pathology, probing depth should not exceed 3 mm across the entire dentoalveolar sulcus;
- Satisfactory level of oral hygiene;
- Absence of general diseases in the stage of exacerbation or decompensation
Show all 12Show fewer
- Non-inclusion criteria:
- Patients who had previous harvesting of CTG from the same donor area;
- Patients with impacted third molars in the donor area;
- Presence of concomitant diseases in the stage of exacerbation or decompensation;
- Patients with oncological diseases, as well as patients who have received radiotherapy and chemotherapy in the last 5 years;
- Patients with a history of smoking for more than 10 years.
Who cannot join
- Patient refusal of further participation in the study;
- Pregnant and breastfeeding women;
- Patients with blood coagulation disorders (haemophilia, Willebrand's disease, intake of anticoagulants);
- Patients with diseases that impair soft tissue healing (insulin-dependent diabetes mellitus).
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
Igor Ashurko
Igor Ashurko
About this study
Official title: Use of a Double-layered Collagen Matrix for Preservation of the Maxillary Tuberosity Area Upon Free Connective Tissue Graft Harvesting
An interventional prospective randomised clinical trial (RCT) in parallel groups is planned. The sample size was 30 patients who will be randomly divided into two groups based on the surgical procedure. The first group is the healing of the donor zone after SCTG harvesting without filling the wound with collagen matrix. The second group is the wound defect closure in the donor area using the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting, severity of pain, postoperative edema, bleeding, analgesic intake and quality of life in the postoperative period will be assessed.
Read the detailed description
The aim of this study is to perform a comparative analysis of the effectiveness of using a double-layer collagen matrix to preserve the parameters of the donor area in the region of the maxillary tuberosity versus healing of the wound surface without its use. Examination and treatment of patients will be carried out on the basis of the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry of I.M. Sechenov First Moscow State Medical University.
The object of the study will be patients with an inclusion defect on the maxilla or mandible within 1-2 teeth combined with a soft tissue thickness deficiency in the area of dental implants (< 2 mm) which requires mucosal augmentation operation. All patients will be randomly divided into two groups depending on the surgical procedure. In 1 group (n=15) the donor area will heal by secondary tension, and in 2 group (n=15) the collagen matrix "FibroMATRIX" will be used to close the wound defect in the donor area. The groups will be comparable in terms of gender and age characteristics. The randomisation of patients will be performed at the stage of surgical intervention as follows: after taking a free connective tissue graft and adapting the CTG to the recipient bed, an envelope with a randomly assigned method of donor area closure will be opened.
Patients in both groups will undergo dental implantation according to the standard protocol and healing abutment installation. In both groups of patients, a free connective tissue graft will be taken from the maxillary tuberosity and the autograft will be fixed to the vestibular full-thickness muco-periosteal flap with horizontal U-shaped sutures, followed by wound closure using simple interrupted sutures without tension.
Further, the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671) will be adapted to the donor area for the patients of the 2 group, the patients of both groups will have to perform suturing of the wound surface using simple interrupted sutures.
In the postoperative period, standard antibacterial and anti-inflammatory therapy should be administered in combination with the use of topical antiseptics for daily care.
- Conditions
- Soft Tissue Atrophy
- Being tested
- Closure of the donor area after CTG harvesting without the use of collagen matrix, Closure of the donor area after CTG harvesting with collagen matrix
- Keywords
- connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation, donor site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the donor area after CTG harvesting without the use of collagen matrixProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant
- Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area
- Suturing of the wound in the donor site.
Closure of the donor area after CTG harvesting with collagen matrixProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant
- Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area
- Adaptation of sterile collagen matrix to the donor site
- Suturing of the wound in the donor site
| Study group | Role | What they receive |
|---|---|---|
| first group | Active comparator | Healing of the donor area will be accomplished without the use of collagen matrix Receives: Procedure: Closure of the donor area after CTG harvesting without the use of collagen matrix |
| second group | Experimental | Closure of the wound defect in the donor area in the region of the maxillary tuberosity will be carried out after CTG harvesting with the use of collagen matrix Receives: Procedure: Closure of the donor area after CTG harvesting with collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany) before the operation and on the 90th day after the operation. Then, the stl files will be compared in the GOM Inspect software and the contour change will be evaluated at 3 equidistant points.
Measured: [Day 90 compared to the 0th day (initial value)]
Secondary outcomes (22)
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany) before the operation and on the 180th day after the operation. Then, the stl files will be compared in the GOM Inspect software and the contour change will be evaluated at 3 equidistant points.
Measured: [Day 180 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: [4 hours compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: [day 1 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: [day 3 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: [day 5 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Measured: [day 7 compared to the 0th day (initial value)]
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Measured: [day 1 compared to the 0th day (initial value)]
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Measured: [day 3 compared to the 0th day (initial value)]
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Measured: [day 5 compared to the 0th day (initial value)]
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Measured: [day 7 compared to the 0th day (initial value)]
Assessment of bleeding
Assessment of the presence of blood taste in the mouth using a scale where 0 - no taste, 1 - periodic taste, 2 - constant taste.
Measured: [day 1 compared to the 0th day (initial value)]
Assessment of bleeding
Assessment of the presence of blood taste in the mouth using a scale where 0 - no taste, 1 - periodic taste, 2 - constant taste.
Measured: [day 3 compared to the 0th day (initial value)]
Assessment of bleeding
Assessment of the presence of blood taste in the mouth using a scale where 0 - no taste, 1 - periodic taste, 2 - constant taste.
Measured: [day 5 compared to the 0th day (initial value)]
Assessment of bleeding
Assessment of the presence of blood taste in the mouth using a scale where 0 - no taste, 1 - periodic taste, 2 - constant taste.
Measured: [day 7 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Measured: [day 1 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Measured: [day 3 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Measured: [day 5 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Measured: [day 7 compared to the 0th day (initial value)]
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Measured: [Day 0 (initial value)]
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Measured: [Day 7 compared to the 0th day (initial value)]
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Measured: [Day 90-93 compared to the 0th day (initial value)]
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Measured: [Day 180-186 compared to the 0th day (initial value)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start17 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AtrophyStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Ashurko, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039839
- Sponsor's protocol ID
- AI-03
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD Sharing is impossible because of the recommendation of the local ethics committee, the provision of data is possible upon receipt of an official request addressed to the chief researcher
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Double-layered Collagen Matrix for Preservation of the Maxillary Tuberosity Area Upon Free Connective Tissue Graft Harvesting
- ClinicalTrials.gov ID
- NCT06039839
- Acronym / sponsor ID
- AI-03
- Conditions
- Soft Tissue Atrophy
- Keywords
- connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation, donor site
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 15 Sep 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.
An interventional prospective randomised clinical trial (RCT) in parallel groups is planned. The sample size was 30 patients who will be randomly divided into two groups based on the surgical procedure. The first group is the healing of the donor zone after SCTG harvesting without filling the wound with collagen matrix. The second group is the wound defect closure in the donor area using the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting, severity of pain, postoperative edema, bleeding, analgesic intake and quality of life in the postoperative period will be assessed.
Detailed description
The aim of this study is to perform a comparative analysis of the effectiveness of using a double-layer collagen matrix to preserve the parameters of the donor area in the region of the maxillary tuberosity versus healing of the wound surface without its use. Examination and treatment of patients will be carried out on the basis of the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry of I.M. Sechenov First Moscow State Medical University.
The object of the study will be patients with an inclusion defect on the maxilla or mandible within 1-2 teeth combined with a soft tissue thickness deficiency in the area of dental implants (< 2 mm) which requires mucosal augmentation operation. All patients will be randomly divided into two groups depending on the surgical procedure. In 1 group (n=15) the donor area will heal by secondary tension, and in 2 group (n=15) the collagen matrix "FibroMATRIX" will be used to close the wound defect in the donor area. The groups will be comparable in terms of gender and age characteristics. The randomisation of patients will be performed at the stage of surgical intervention as follows: after taking a free connective tissue graft and adapting the CTG to the recipient bed, an envelope with a randomly assigned method of donor area closure will be opened.
Patients in both groups will undergo dental implantation according to the standard protocol and healing abutment installation. In both groups of patients, a free connective tissue graft will be taken from the maxillary tuberosity and the autograft will be fixed to the vestibular full-thickness muco-periosteal flap with horizontal U-shaped sutures, followed by wound closure using simple interrupted sutures without tension.
Further, the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671) will be adapted to the donor area for the patients of the 2 group, the patients of both groups will have to perform suturing of the wound surface using simple interrupted sutures.
In the postoperative period, standard antibacterial and anti-inflammatory therapy should be administered in combination with the use of topical antiseptics for daily care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Active comparator | Procedure: Closure of the donor area after CTG harvesting without the use of collagen matrixHealing of the donor area will be accomplished without the use of collagen matrix |
| second group | Experimental | Procedure: Closure of the donor area after CTG harvesting with collagen matrixClosure of the wound defect in the donor area in the region of the maxillary tuberosity will be carried out after CTG harvesting with the use of collagen matrix |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Presence of written informed consent of the patient to participate in the study;
- Age between 18 and 45 years;
- Included defects on the maxilla or mandible within 1-2 teeth combined with soft tissue thickness deficiency in the area of dental implants (< 2 mm);
- Teeth without periodontal pathology, probing depth should not exceed 3 mm across the entire dentoalveolar sulcus;
- Satisfactory level of oral hygiene;
Key exclusion criteria (4 listed)
- Patient refusal of further participation in the study;
- Pregnant and breastfeeding women;
- Patients with blood coagulation disorders (haemophilia, Willebrand's disease, intake of anticoagulants);
- Patients with diseases that impair soft tissue healing (insulin-dependent diabetes mellitus).
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 |
|---|---|---|
| Closure of the donor area after CTG harvesting without the use of collagen matrix1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant 2. Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area 3. Suturing of the wound in the donor site. | Procedure or surgery | first group |
| Closure of the donor area after CTG harvesting with collagen matrix1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant 2. Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area 3. Adaptation of sterile collagen matrix to the donor site 4. Suturing of the wound in the donor site | Procedure or surgery | second group |
Primary outcome
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting
Time frame: [Day 90 compared to the 0th day (initial value)]
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany) before the operation and on the 90th day after the operation. Then, the stl files will be compared in the GOM Inspect software and the contour change will be evaluated at 3 equidistant points.
22 secondary outcomes
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting
Time frame: [Day 180 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Time frame: [4 hours compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Time frame: [day 1 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Time frame: [day 3 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Time frame: [day 5 compared to the 0th day (initial value)]
Assessment of the severity of pain syndrome
Time frame: [day 7 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [day 1 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [day 3 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [day 5 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [day 7 compared to the 0th day (initial value)]
Assessment of bleeding
Time frame: [day 1 compared to the 0th day (initial value)]
Assessment of bleeding
Time frame: [day 3 compared to the 0th day (initial value)]
Assessment of bleeding
Time frame: [day 5 compared to the 0th day (initial value)]
Assessment of bleeding
Time frame: [day 7 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Time frame: [day 1 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Time frame: [day 3 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Time frame: [day 5 compared to the 0th day (initial value)]
Assessment of consumption of analgesics
Time frame: [day 7 compared to the 0th day (initial value)]
Assessment of the quality of life
Time frame: [Day 0 (initial value)]
Assessment of the quality of life
Time frame: [Day 7 compared to the 0th day (initial value)]
Assessment of the quality of life
Time frame: [Day 90-93 compared to the 0th day (initial value)]
Assessment of the quality of life
Time frame: [Day 180-186 compared to the 0th day (initial value)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. IPD Sharing is impossible because of the recommendation of the local ethics committee, the provision of data is possible upon receipt of an official request addressed to the chief researcher
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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.
Igor Ashurko principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov 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 Closure of the donor area after CTG harvesting without the use of collagen matrix and Closure of the donor area after CTG harvesting with collagen matrix in people with Soft Tissue Atrophy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 12 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: status not confirmed, as of the sponsor's last update on 15 Sep 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Ashurko (+7-926-515-05-55, ashurko_i_p@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting (time frame: [Day 90 compared to the 0th day (initial value)]). 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 15 Sep 2023.