Soft Tissue AtrophyNCT05551962
Increasing the Thickness of Soft Tissues in the Esthetic Zone Around Implants
A study testing Soft tissue augmentation with CTG and Soft tissue augmentation with CM in people with Soft Tissue Atrophy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
This is an interventional prospective randomized clinical trial (RCT) in parallel groups. This study is aimed at detecting a difference in the increase in the thickness of soft tissues of at least 0.3 mm between the two groups (the standard deviation [SD] of 0.3 mm and the average value of 1.2 mm was borrowed from an… 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?
- Soft tissue augmentation with CTG and Soft tissue augmentation with CM
- 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
- 9 Jun 2022to 15 Apr 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The presence of written informed consent of the patient to participate in the study;
- Age from 18 to 45 years;
- The presence of an included defect in the esthetic zone part of maxilla with a sufficient volume of bone tissue;
- Soft tissue thickness <3 mm on the vestibular side;
- Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow;
- Satisfactory level of oral hygiene;
Show all 15Show fewer
- Patients without concomitant pathology or with concomitant pathology in the compensation stage.
- Non-inclusion criteria:
- Age less than 18 and more than 45 years;
- Heavy smokers (more than 10 cigarettes a day);
- Patients with somatic diseases in the stage of decompensation or in the stage of exacerbation;
- Patients with malignant tumors, as well as patients with a history of radiation and chemotherapy over the past 5 years;
- Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drugs, steroid drugs);
- Pregnancy and breastfeeding;
- Patients with mental disorders.
Who cannot join
- Patients with infections either periodontally or periapically, which developed after inclusion in the study;
- Pregnancy following entrance into the study;
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
- Patients who, for one reason or another, could not complete the entire protocol to the end.
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, +7-926-515-05-55, ashurko_i_p@staff.sechenov.ru
Daria Krylova, +7-916-017-24-70, saveleva_d_a@student.sechenov.ru
About this study
Official title: Comparative Analysis of the Effectiveness of Various Methods of Increasing the Thickness of Soft Tissues During Dental Implantation in the Esthetic Zone of the Maxilla
This is an interventional prospective randomized clinical trial (RCT) in parallel groups. This study is aimed at detecting a difference in the increase in the thickness of soft tissues of at least 0.3 mm between the two groups (the standard deviation [SD] of 0.3 mm and the average value of 1.2 mm was borrowed from an article published by Cairo F et al., 2017). Using SampleSizeCalculator, it was calculated that the number of patients in each group should be 14 (alpha = 0.05; power = 80%). This number was increased by 10%, taking into account possible exceptions from the study. The sample size is 30 patients who will be randomly divided into two groups depending on the surgical intervention used. First group - patients will undergo increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the maxilla or palate. Second group - patients will undergo increasing the thickness of the mucous membrane using collagen matrix "Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ-20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain syndrome, collateral edema, Doppler flowmetry, probing depth, soft tissue aesthetics, keratinized mucosa width and quality of life will be assessed. In addition, after 3 months simultaneously with installation of gingiva formers biopsy specimens will be sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Read the detailed description
The aim of this research is to perform a comparative clinical and histomorphometric analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty patients diagnosed with partial absence of teeth will be examined 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. Patients have a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the esthetic zone of the maxilla, which is an indication for its increase. All patients will be randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=15) transplantation of a free connective tissue graft (CTG) from tuberosity area of the maxilla or palate is performed. In 2 group (n=15) collagen matrix "Fibro-Gide" will be used. According to gender and age characteristics, both groups will be comparable. Randomization of patients will be carried out at the stage of surgical intervention as follows: after a dental implant placement and preparation of recipient's bed, an envelope with a randomly assigned treatment method (using a connective tissue graft or a collagen matrix) will be opened.
During the operation, incision will be made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap will be elevated. Traditional 2-stage dental implantation is performed according to surgical protocols of dental implant systems Astra Tech (Dentsply Implants Manufacturing GmbH, Germany; registration in Russia 27.12.2019 No FSZ 2015/3214). A free connective tissue graft will be harvested in patients of the first group. Graft will be fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap. In second patients group a fragment of the collagen matrix "Fibro-Gide" will be fixed to the buccal muco-periosteal flap (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ - 20207/11765). For patients of all groups mobilization of the muco-periosteal flap conducts followed by suturing the wound tightly without tension with simple interrupted sutures.
Postoperative recommendations will include rinsing with 0.2% chlorhexidine gluconate mouthwash solution (Corsodyl, GlaxoSmithKline 77.99.11.915.Д.005285.07.03) twice a day for a week and receiving antibiotic (Amoxicillin + Clavulanic Acid, 1 g Amoxiclav, LEK, d.d., Slovenia, 22.07.2011, П N012124/01) twice a day for 5 days. To relieve pain, 100 mg of Nimesulide (Nise; Dr. Reddy's Laboratories Ltd., India, 26.05.2009, П N012824/03) will be prescribed. The stage of the implant uncovering with hilling abutments installation is carried out 3 months after the intervention. At this stage, a soft tissue fragment will be taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study we will use both conventional light microscopy (microscopy in the light field) and polarizing microscopy - to estimate the content of collagen fibers in preparations stained with picrosirius red. During a morphometric study we will carry out a quantitative assessment of the characteristics of the epithelial layer, the basement membrane relative length (the ratio of the absolute length of the basement membrane to the length of the epithelial layer), the characteristics of the underlying connective tissue.
- Conditions
- Soft Tissue Atrophy
- Being tested
- Soft tissue augmentation with CTG, Soft tissue augmentation with CM
- Keywords
- connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation with CTGProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation
- Placement of the Astra Tech dental implant (Dentsply, Germany)
- Sampling of free connective tissue graft from the maxilla tuber area
- Fixation of the graft to the vestibular flap
- Suturing the wound tightly
Soft tissue augmentation with CMProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation
- Placement of the Astra Tech dental implant (Dentsply, Germany)
- Modeling of sterile collagen matrix according to the shape of the recipient bed
- Fixation of the collagen matrix to the vestibular flap
- Suturing the wound tightly
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | The patients undergo implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuber region on the maxilla or palate. Receives: Procedure: Soft tissue augmentation with CTG |
| Second group | Experimental | The patients undergo implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide" Receives: Procedure: Soft tissue augmentation with CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of soft tissue thickness gain
The value of the increase in the thickness of soft tissues in the study area (mm) on the 90th day 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, 16.05.2019, № РД-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files will be compared and the vestibular contour changes will be evaluated at 3 equidistant points in the coronary-apical direction.
Measured: Day 90 compared to the 0th day (initial value)
Secondary outcomes (17)
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome is 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 is 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 is 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 collateral edema
Edema will be 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 will be 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 will be 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 the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Measured: Day 7 compared to the 0th day (initial value)
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Measured: Day 90-93 compared to the 0th day (initial value)
Assessment of the quality of life
The patient's quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Measured: Day 180-186 compared to the 0th day (initial value)
Doppler flowmetry
Doppler flowmetry will be carried out using the LAKK-02 apparatus (LLC Scientific and Production Enterprise "LAZMA" Russia) Registration certificate of the Ministry of Health of the Russian Federation No.29/03020703/5555-03 dated 11.09.2003).
Measured: Day 7 compared to the 0th day (initial value)
Doppler flowmetry
Doppler flowmetry will be carried out using the LAKK-02 apparatus (LLC Scientific and Production Enterprise "LAZMA" Russia) Registration certificate of the Ministry of Health of the Russian Federation No.29/03020703/5555-03 dated 11.09.2003).
Measured: Day 30-31 compared to the 0th day (initial value)
Doppler flowmetry
Doppler flowmetry will be carried out using the LAKK-02 apparatus (LLC Scientific and Production Enterprise "LAZMA" Russia) Registration certificate of the Ministry of Health of the Russian Federation No.29/03020703/5555-03 dated 11.09.2003).
Measured: Day 90-93 compared to the 0th day (initial value)
Doppler flowmetry
Doppler flowmetry will be carried out using the LAKK-02 apparatus (LLC Scientific and Production Enterprise "LAZMA" Russia) Registration certificate of the Ministry of Health of the Russian Federation No.29/03020703/5555-03 dated 11.09.2003).
Measured: Day 180-186 compared to the 0th day (initial value)
Histomorphometric analysis
Simultaneously with installation of gingiva formers, a soft tissue fragment is taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study, we use both conventional light microscopy (microscopy in the light field) and polarizing microscopy - to estimate the content of collagen fibers in preparations stained with picrosirius red. During a morphometric study, we carry out a quantitative assessment of the characteristics of the epithelial layer, the basement membrane relative length (the ratio of the absolute length of the basement membrane to the length of the epithelial layer), the characteristics of the underlying connective tissue.
Measured: Day 90-93 compared to the 0th day (initial value)
Soft tissue aesthetics
Evaluation of soft tissue aesthetics will be carried out by visual inspection taking into account the PES (pink aesthetic score).
Measured: Day 180-186 compared to the 0th day (initial value)
Keratinized mucosa width
Evaluation of the keratinized mucosa width will be carried out using a periodontal probe.
Measured: Day 180-186 compared to the 0th day (initial value)
Probing depth
The probing depth will be carried out using a periodontal probe in the medial and distal papillae
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 posted23 Sep 2022
- Study start9 Jun 2022
- Primary completion10 Dec 2022 (estimated)
- Study completion15 Apr 2023 (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
- NCT05551962
- Sponsor's protocol ID
- 10012022
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 23 Sep 2022
- 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Effectiveness of Various Methods of Increasing the Thickness of Soft Tissues During Dental Implantation in the Esthetic Zone of the Maxilla
- ClinicalTrials.gov ID
- NCT05551962
- Acronym / sponsor ID
- 10012022
- Conditions
- Soft Tissue Atrophy
- Keywords
- connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation
- 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
- 9 Jun 2022 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 23 Sep 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.
This is an interventional prospective randomized clinical trial (RCT) in parallel groups. This study is aimed at detecting a difference in the increase in the thickness of soft tissues of at least 0.3 mm between the two groups (the standard deviation [SD] of 0.3 mm and the average value of 1.2 mm was borrowed from an article published by Cairo F et al., 2017). Using SampleSizeCalculator, it was calculated that the number of patients in each group should be 14 (alpha = 0.05; power = 80%). This number was increased by 10%, taking into account possible exceptions from the study. The sample size is 30 patients who will be randomly divided into two groups depending on the surgical intervention used. First group - patients will undergo increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the maxilla or palate. Second group - patients will undergo increasing the thickness of the mucous membrane using collagen matrix "Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ-20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain syndrome, collateral edema, Doppler flowmetry, probing depth, soft tissue aesthetics, keratinized mucosa width and quality of life will be assessed. In addition, after 3 months simultaneously with installation of gingiva formers biopsy specimens will be sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Detailed description
The aim of this research is to perform a comparative clinical and histomorphometric analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty patients diagnosed with partial absence of teeth will be examined 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. Patients have a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the esthetic zone of the maxilla, which is an indication for its increase. All patients will be randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=15) transplantation of a free connective tissue graft (CTG) from tuberosity area of the maxilla or palate is performed. In 2 group (n=15) collagen matrix "Fibro-Gide" will be used. According to gender and age characteristics, both groups will be comparable. Randomization of patients will be carried out at the stage of surgical intervention as follows: after a dental implant placement and preparation of recipient's bed, an envelope with a randomly assigned treatment method (using a connective tissue graft or a collagen matrix) will be opened.
During the operation, incision will be made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap will be elevated. Traditional 2-stage dental implantation is performed according to surgical protocols of dental implant systems Astra Tech (Dentsply Implants Manufacturing GmbH, Germany; registration in Russia 27.12.2019 No FSZ 2015/3214). A free connective tissue graft will be harvested in patients of the first group. Graft will be fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap. In second patients group a fragment of the collagen matrix "Fibro-Gide" will be fixed to the buccal muco-periosteal flap (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ - 20207/11765). For patients of all groups mobilization of the muco-periosteal flap conducts followed by suturing the wound tightly without tension with simple interrupted sutures.
Postoperative recommendations will include rinsing with 0.2% chlorhexidine gluconate mouthwash solution (Corsodyl, GlaxoSmithKline 77.99.11.915.Д.005285.07.03) twice a day for a week and receiving antibiotic (Amoxicillin + Clavulanic Acid, 1 g Amoxiclav, LEK, d.d., Slovenia, 22.07.2011, П N012124/01) twice a day for 5 days. To relieve pain, 100 mg of Nimesulide (Nise; Dr. Reddy's Laboratories Ltd., India, 26.05.2009, П N012824/03) will be prescribed. The stage of the implant uncovering with hilling abutments installation is carried out 3 months after the intervention. At this stage, a soft tissue fragment will be taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study we will use both conventional light microscopy (microscopy in the light field) and polarizing microscopy - to estimate the content of collagen fibers in preparations stained with picrosirius red. During a morphometric study we will carry out a quantitative assessment of the characteristics of the epithelial layer, the basement membrane relative length (the ratio of the absolute length of the basement membrane to the length of the epithelial layer), the characteristics of the underlying connective tissue.
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: Soft tissue augmentation with CTGThe patients undergo implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuber region on the maxilla or palate. |
| Second group | Experimental | Procedure: Soft tissue augmentation with CMThe patients undergo implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide" |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- The presence of written informed consent of the patient to participate in the study;
- Age from 18 to 45 years;
- The presence of an included defect in the esthetic zone part of maxilla with a sufficient volume of bone tissue;
- Soft tissue thickness <3 mm on the vestibular side;
- Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow;
Key exclusion criteria (4 listed)
- Patients with infections either periodontally or periapically, which developed after inclusion in the study;
- Pregnancy following entrance into the study;
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
- Patients who, for one reason or another, could not complete the entire protocol to the end.
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 |
|---|---|---|
| Soft tissue augmentation with CTG1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 3. Sampling of free connective tissue graft from the maxilla tuber area 4. Fixation of the graft to the vestibular flap 5. Suturing the wound tightly | Procedure or surgery | First group |
| Soft tissue augmentation with CM1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 3. Modeling of sterile collagen matrix according to the shape of the recipient bed 4. Fixation of the collagen matrix to the vestibular flap 5. Suturing the wound tightly | Procedure or surgery | Second group |
Primary outcome
The amount of soft tissue thickness gain
Time frame: Day 90 compared to the 0th day (initial value)
The value of the increase in the thickness of soft tissues in the study area (mm) on the 90th day 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, 16.05.2019, № РД-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files will be compared and the vestibular contour changes will be evaluated at 3 equidistant points in the coronary-apical direction.
17 secondary outcomes
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 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 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)
Doppler flowmetry
Time frame: Day 7 compared to the 0th day (initial value)
Doppler flowmetry
Time frame: Day 30-31 compared to the 0th day (initial value)
Doppler flowmetry
Time frame: Day 90-93 compared to the 0th day (initial value)
Doppler flowmetry
Time frame: Day 180-186 compared to the 0th day (initial value)
Histomorphometric analysis
Time frame: Day 90-93 compared to the 0th day (initial value)
Soft tissue aesthetics
Time frame: Day 180-186 compared to the 0th day (initial value)
Keratinized mucosa width
Time frame: Day 180-186 compared to the 0th day (initial value)
Probing depth
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 23 Sep 2022.
- 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 Soft tissue augmentation with CTG and Soft tissue augmentation with CM 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 15 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 23 Sep 2022. 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?
The amount of soft tissue thickness gain (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 23 Sep 2022.