Soft Tissue AtrophyNCT05870774
Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results
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 was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. Read more about this study
- Who is it for?
- Ages 25 to 59 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
- 52 participants
- Where
- 1 siteRussia
- Study dates
- 28 Oct 2021to 18 May 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 25 to 59 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 25 to 59 years;
- The presence of an included defect in the distal part of the lower jaw 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 25 and more than 59 years;
- Hard smokers (more than 10 cigarettes a day);
- The presence of concomitant pathology in the stage of decompensation;
- 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
I.M. Sechenov First Moscow State Medical University
Moscow, 119991
About this study
Official title: Soft Tissue Augmentation Around Implants With Collagen Matrix and Autogenous Graft: 6-months Prospective Randomized Controlled Clinical Trial
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used 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, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.
Read the detailed description
The aim of this research was to perform a comparative clinical analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty two patients diagnosed with partial absence of teeth was 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 had a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the distal parts of the mandible, which was an indication for its increase. All patients were randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=16) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=16) collagen matrix "Fibro-Gide" was used. According to gender and age characteristics, both groups were comparable. Randomization of patients was 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) was opened.
During the operation, incision was made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap was elevated. Traditional 2-stage dental implantation was 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 was harvested in patients of the first group. Graft was 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" was 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 conducted followed by suturing the wound tightly without tension with simple interrupted sutures.
Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed.
- 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)
- Harvesting of free connective tissue graft from the maxilla tuberosity area
- Fixation of the graft to the vestibular mucosal-periosteal 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 mucosal-periosteal flap
- Suturing the wound tightly
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | The patients underwent implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuberosity area of the upper jaw Receives: Procedure: Soft tissue augmentation with CTG |
| Second group | Experimental | The patients underwent 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 soft tissue thickness gain in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
Measured: [Day 90 compared to the 0th day (initial value)]
Secondary outcomes (23)
The amount of soft tissue thickness gain
The value of soft tissue thickness gain in the study area (mm) on the 180th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 180th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
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: [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 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 90 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 180 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 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 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).]
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Measured: [Day 0 (initial value)]
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Measured: [Day 90-93 compared to the 0th day (initial value)].
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Measured: [Day 180-186 compared to the 0th day (initial value)].
Soft tissue aesthetics
Evaluation of soft tissue aesthetics was carried out by visual inspection taking into account the PES (pink aesthetic score). The evaluation was carried out according to a score of 0-1-2, where 0 was the lowest value and 2 was the highest, the maximum achievable PES value was 14.
Measured: [Day 180-186 compared to the 0th day (initial value) ]
Microbiota Evaluation
At 3 months, mucosal swabs from the implant emergence profile were collected and transported in Amies medium. Samples were cultured on selective and blood agar under aerobic and anaerobic conditions. Colonies were counted and identified using biochemical tests and MALDI-TOF mass spectrometry (score ≥2.0 considered reliable). Species diversity with clinically significant growth (CFU/mL ≥ 105); microbiome formation duration (p=0.04131); the expression of the TNFα gene were evaluated.
Measured: [Day 90]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start28 Oct 2021
- Primary completion25 Dec 2022
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 52 participants (actual)
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, ass.prof., Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870774
- Sponsor's protocol ID
- AI-02
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashurko I, Bokareva S, Svitich O, Tarasenko S, Kompaniets D, Avagyan A, Vartanova N, Rasana M, Unkovskiy A. Depth of implant mucosal tunnel influences its microbiota: a prospective observational cross-sectional study. BMC Oral Health. 2026 Jul 17;26(1):1276. doi: 10.1186/s12903-026-09312-4.
PubMed 42469774Ashurko I, Tarasenko S, Magdalyanova M, Balyasin M, Galyas A, Kazumyan S, Safi N, Unkovskiy A. 3D-Analysis of Peri-Implant Soft Tissue Gain With Collagen Matrix and Connective Tissue Graft: A Randomized Control Trial. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70043. doi: 10.1111/cid.70043.
PubMed 40254798
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Augmentation Around Implants With Collagen Matrix and Autogenous Graft: 6-months Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05870774
- Acronym / sponsor ID
- AI-02
- 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
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 23 May 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.
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used 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, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.
Detailed description
The aim of this research was to perform a comparative clinical analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty two patients diagnosed with partial absence of teeth was 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 had a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the distal parts of the mandible, which was an indication for its increase. All patients were randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=16) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=16) collagen matrix "Fibro-Gide" was used. According to gender and age characteristics, both groups were comparable. Randomization of patients was 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) was opened.
During the operation, incision was made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap was elevated. Traditional 2-stage dental implantation was 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 was harvested in patients of the first group. Graft was 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" was 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 conducted followed by suturing the wound tightly without tension with simple interrupted sutures.
Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed.
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 underwent implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuberosity area of the upper jaw |
| Second group | Experimental | Procedure: Soft tissue augmentation with CMThe patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide" |
Who may qualify
- Ages
- 25 to 59 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 25 to 59 years;
- The presence of an included defect in the distal part of the lower jaw 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. Harvesting of free connective tissue graft from the maxilla tuberosity area 4. Fixation of the graft to the vestibular mucosal-periosteal 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 mucosal-periosteal 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 soft tissue thickness gain in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
23 secondary outcomes
The amount of soft tissue thickness gain
Time frame: [Day 180 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 severity of pain syndrome
Time frame: [Day 90 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome
Time frame: [Day 180 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 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 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).]
Attached mucosa measurement
Time frame: [Day 0 (initial value)]
Attached mucosa measurement
Time frame: [Day 90-93 compared to the 0th day (initial value)].
Attached mucosa measurement
Time frame: [Day 180-186 compared to the 0th day (initial value)].
Soft tissue aesthetics
Time frame: [Day 180-186 compared to the 0th day (initial value) ]
Microbiota Evaluation
Time frame: [Day 90]
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 26 Sep 2025.
- Derived from this study: PubMed 42469774Ashurko I, Bokareva S, Svitich O, Tarasenko S, Kompaniets D, Avagyan A, Vartanova N, Rasana M, Unkovskiy A. Depth of implant mucosal tunnel influences its microbiota: a prospective observational cross-sectional study. BMC Oral Health. 2026 Jul 17;26(1):1276. doi: 10.1186/s12903-026-09312-4.
- Derived from this study: PubMed 40254798Ashurko I, Tarasenko S, Magdalyanova M, Balyasin M, Galyas A, Kazumyan S, Safi N, Unkovskiy A. 3D-Analysis of Peri-Implant Soft Tissue Gain With Collagen Matrix and Connective Tissue Graft: A Randomized Control Trial. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70043. doi: 10.1111/cid.70043.
- 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.
Igor Ashurko, ass.prof. principal investigator
I.M. Sechenov First Moscow State Medical 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: finished, as of the sponsor's last update on 26 Sep 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 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?
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?
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?
On the ClinicalTrials.gov record for NCT05870774, which also lists 2 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 26 Sep 2025.