An interventional study of Soft tissue augmentation with CTG and Soft tissue augmentation with CM in Soft Tissue Atrophy, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russia. Open to participants aged 25 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
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.
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Non-inclusion criteria:
Exclusion Criteria:
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
Procedure: Soft tissue augmentation with CTG
The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide"
Procedure: Soft tissue augmentation with CM
1. 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
1. 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
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).
Time frame: [Day 90 compared to the 0th day (initial value)]
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).
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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).
Time frame: [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).
Time frame: [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).
Time frame: [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).
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [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.
Time frame: [Day 90]
Plan to share: No
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I.M. Sechenov First Moscow State Medical University