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A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first group | Active Comparator | Patients will receive a free connective tissue graft without an epithelial collar |
|
| second group | Experimental | Patients will receive a free connective tissue graft with epithelial collar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free connective tissue graft without an epithelial collar | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Width of Keratinized Mucosa | Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points. | Day 90 compared to the 0th day (initial value) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Width of Keratinized Mucosa | Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points. |
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Non-inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor P Ashurko | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russia |
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| Free connective tissue graft with epithelial collar | Procedure |
|
|
| Day 180 compared to the 0th day (initial value) |
| Assessment of Scar Formation According to the Modified Scar Index (MSI) | Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary. | Day 90 compared to the 0th day (initial value) |
| Assessment of Scar Formation According to the Modified Scar Index (MSI) | Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary. | Day 180 compared to the 0th day (initial value) |
| Assessment of Pain Severity | Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain. | 4 hours compared to the 0th day (initial value) |
| Assessment of Pain Severity | Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain. | Day 1 compared to the 0th day (initial value) |
| Assessment of Pain Severity | Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain. | Day 3 compared to the 0th day (initial value) |
| Assessment of Pain Severity | Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain. | Day 5 compared to the 0th day (initial value) |
| Assessment of Pain Severity | Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain. | Day 7 compared to the 0th day (initial value) |
| Assessment of Postoperative Swelling Severity | Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling. | Day 1 compared to the 0th day (initial value) |
| Assessment of Postoperative Swelling Severity | Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling. | Day 3 compared to the 0th day (initial value) |
| Assessment of Postoperative Swelling Severity | Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling. | Day 5 compared to the 0th day (initial value) |
| Assessment of Postoperative Swelling Severity | Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling. | Day 7 compared to the 0th day (initial value) |
| Assessment of Bleeding | Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste. | Day 1 compared to the 0th day (initial value) |
| Assessment of Bleeding | Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste. | Day 3 compared to the 0th day (initial value) |
| Assessment of Bleeding | Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste. | Day 5 compared to the 0th day (initial value) |
| Assessment of Bleeding | Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste. | Day 7 compared to the 0th day (initial value) |
| Assessment of Analgesic Intake | Assessment of the number of Nimesulide 100 mg tablets taken per day. | Day 1 compared to the 0th day (initial value) |
| Assessment of Analgesic Intake | Assessment of the number of Nimesulide 100 mg tablets taken per day. | Day 3 compared to the 0th day (initial value) |
| Assessment of Analgesic Intake | Assessment of the number of Nimesulide 100 mg tablets taken per day. | Day 5 compared to the 0th day (initial value) |
| Assessment of Analgesic Intake | Assessment of the number of Nimesulide 100 mg tablets taken per day. | Day 7 compared to the 0th day (initial value) |
| Quality of Life Assessment According to OHIP-14 | Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced. | Day 0 (initial value) |
| Quality of Life Assessment According to OHIP-14 | Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced. | Day 7 compared to the 0th day (initial value) |
| Quality of Life Assessment According to OHIP-14 | Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced. | Day 90-93 compared to the 0th day (initial value) |
| Quality of Life Assessment According to OHIP-14 | Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced. | Day 180-186 compared to the 0th day (initial value) |