Soft Tissue AtrophyNCT05123898
Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants
A study testing Soft tissue augmentation 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 35 patients who were randomly divided into two groups depending on the surgical intervention used. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Soft Tissue Atrophy
- What is being tested?
- Soft tissue augmentation
- 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
- 14 Jan 2020to 20 Nov 2021
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of written informed consent of the patient to participate in the study;
- The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue;
- Deficiency of soft tissue thickness;
- Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth > 3 mm in any site of adjacent teeth;
- 6. Satisfactory level of oral hygiene, namely full mouth plaque score < 20% and full mouth bleeding score < 20%;
- Non-inclusion criteria:
Show all 11Show fewer
- The presence of concomitant pathology in the stage of decompensation;
- Hard smokers (more than 10 cigarettes per day);
- Radio and chemotherapy in history over the past 5 years;
- Pregnancy and breastfeeding;
- Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs).
Who cannot join
- Patients with infections either periodontally or periapically;
- Pregnantcy following entrance into the study;
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
- Subjects, who in the opinion of the investigator, for any reason will not be able to complete the study per protocol.
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: Comparative Analysis of the Effectiveness of Free Connective Tissue Graft and Xenogenic Collagen Matrix Transplantation in Patients With Dental Implants.
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 35 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 "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were 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 was to perform a comparative clinical and histomorphometric analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty five patients diagnosed with partial absence of teeth were 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 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=15) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=20) collagen matrix "Fibromatrix" 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 Ostem (Osstem Implant Co., Ltd., Korea; registration in Russia 05.09.2018 No FSZ 2018/7577). 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 "Fibromatrix" was fixed to the buccal muco-periosteal flap (LLC "Cardioplant", Russia; registration in Russia 20.05.2019 No № FSZ 2019/83671). For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures.
In the early postoperative period the standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed. The stage of the implant uncovering with hilling abutments installation was carried out 3 months after the intervention. At this stage, a soft tissue fragment was taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study we used 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 carried 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
- 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 augmentationProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation
- Placement of the Ostem dental implant (Osstem Implant Co., Ltd.)
- 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 |
|---|---|---|
| 1 group | Other | The patients underwent 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 upper jaw. Receives: Procedure: Soft tissue augmentation |
| 2 group | Experimental | The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibromatrix" Receives: Procedure: Soft tissue augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of soft tissue thickness gain
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA) 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: Days 90
Secondary outcomes (12)
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 1 day
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 3 days
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 5 days
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 7 days
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 30 days
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Measured: 90 days
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Measured: 0 day
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Measured: 7 days
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Measured: 30 days
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Measured: 90 days
Attached mucosa measurement
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.
Measured: 0 day
Attached mucosa measurement
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start14 Jan 2020
- Primary completion28 Jul 2021
- Study completion20 Nov 2021 (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 (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123898
- Sponsor's protocol ID
- 09102019
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Effectiveness of Free Connective Tissue Graft and Xenogenic Collagen Matrix Transplantation in Patients With Dental Implants.
- ClinicalTrials.gov ID
- NCT05123898
- Acronym / sponsor ID
- 09102019
- 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 (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 17 Nov 2021 (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 35 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 "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Detailed description
The aim of this research was to perform a comparative clinical and histomorphometric analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty five patients diagnosed with partial absence of teeth were 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 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=15) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=20) collagen matrix "Fibromatrix" 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 Ostem (Osstem Implant Co., Ltd., Korea; registration in Russia 05.09.2018 No FSZ 2018/7577). 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 "Fibromatrix" was fixed to the buccal muco-periosteal flap (LLC "Cardioplant", Russia; registration in Russia 20.05.2019 No № FSZ 2019/83671). For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures.
In the early postoperative period the standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed. The stage of the implant uncovering with hilling abutments installation was carried out 3 months after the intervention. At this stage, a soft tissue fragment was taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study we used 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 carried 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 |
|---|---|---|
| 1 group | Other | Procedure: Soft tissue augmentationThe patients underwent 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 upper jaw. |
| 2 group | Experimental | Procedure: Soft tissue augmentationThe patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibromatrix" |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The presence of written informed consent of the patient to participate in the study;
- The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue;
- Deficiency of soft tissue thickness;
- Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth > 3 mm in any site of adjacent teeth;
- 6. Satisfactory level of oral hygiene, namely full mouth plaque score < 20% and full mouth bleeding score < 20%;
Key exclusion criteria (4 listed)
- Patients with infections either periodontally or periapically;
- Pregnantcy following entrance into the study;
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
- Subjects, who in the opinion of the investigator, for any reason will not be able to complete the study per protocol.
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 augmentation1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Ostem dental implant (Osstem Implant Co., Ltd.) 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 | 1 group, 2 group |
Primary outcome
The amount of soft tissue thickness gain
Time frame: Days 90
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA) 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.
12 secondary outcomes
VAS scale
Time frame: 1 day
VAS scale
Time frame: 3 days
VAS scale
Time frame: 5 days
VAS scale
Time frame: 7 days
VAS scale
Time frame: 30 days
VAS scale
Time frame: 90 days
OHIP-14 questionnaire
Time frame: 0 day
OHIP-14 questionnaire
Time frame: 7 days
OHIP-14 questionnaire
Time frame: 30 days
OHIP-14 questionnaire
Time frame: 90 days
Attached mucosa measurement
Time frame: 0 day
Attached mucosa measurement
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No. IPD Sharing is impossible because of the recommendation of the local ethics committee
Related trials for Soft Tissue Atrophy
RecruitingPhase 4
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Volume Loss (Soft Tissue Ptosis or Atrophy )
Active, not recruiting
Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
Soft Tissue Atrophy
Active, not recruiting
Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
Soft Tissue Atrophy
RecruitingPhase 4
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge
Active, not recruiting
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation At Dental Implants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 11 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 17 Nov 2021. 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?
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: Days 90). 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 17 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.