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An interventional prospective randomized clinical trial (RCT) was conducted in parallel groups. The sample size consisted of 30 patients who were randomly assigned to two groups based on the type of surgical intervention. The first group received implants with a sloped edge platform (Dentsply Sirona CIS, ASTRA TECH Implant System, registered in Russia on 21/12/2019, No. РЗН 2015/3214). The second group received implants with bone grafting. The assessment in the postoperative period included evaluating the condition of the soft tissues, bone resorption, number of analgesics, duration of the operation, edema, keratinized mucosa width, implant stability quotient, pain severity, and quality of life.
The research aimed to compare the clinical and radiological assessment of soft and hard tissues surrounding implants with a sloped edge platform. Thirty patients with alveolar ridge atrophy were examined at the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry, I.M. Sechenov First Moscow State Medical University. These patients displayed a deficiency in hard tissue width, necessitating augmentation for dental implant placement. Patients were randomly divided into two groups based on treatment methods. The first group received implants with a sloped edge platform (Dentsply Sirona CIS, ASTRA TECH Implant System, registered in Russia on 21/12/2019, No. РЗН 2015/3214). The second group underwent treatment with implants of a "standard" design combined with bone grafting. Gender and age characteristics were matched between the groups for comparability.
Patients in the first group were implanted with sloped edge platform implants, while the second group received implants with a different design (Dentsply Sirona CIS, ASTRA TECH Implant System, registered in Russia on 21/12/2019, No. РЗН 2015/3214) incorporating guided bone regeneration. All groups underwent muco-periosteal flap mobilization followed by wound closure without tension using simple interrupted sutures.
In the early postoperative phase, antibacterial and anti-inflammatory therapy was combined with the use of local antiseptics for daily care. Implant uncovering with healing abutment installation occurred 4-6 months post-intervention. The postoperative assessments included evaluating soft tissue condition, bone resorption, analgesic consumption, operation duration, edema, keratinized mucosa width, implant stability quotient, pain severity, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slope Implant | Experimental | The patients received implants with a sloped platform edge. |
|
| Implant and guided bone regeneration | Active Comparator | The patients received implants and guided bone regeneration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implantation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| determination of the level of the marginal bone | This parameter was determined by analyzing radiovisiography performed on the Vatech EzSensor device (Vatech, South Korea) with an X-ray load of 2μSv 6 months after the operation (after completion of prosthetics). The radiographs were studied using X-ray software on a 27-inch monitor (ASUS) with a screen resolution of 2560 × 1440 pixels. The marginal bone level was assessed using a measuring tool built into the program. The reference point for measurement was the implant shoulder on the medial and distal sides. | Day 180 compared to the 0th day (initial value) |
| Measure | Description | Time Frame |
|---|---|---|
| Attached mucosa measurement | Evaluation of the width of the keratinized gum will be carried out using a periodontological probe. The width is measured between the mucosal-gingival junction between the vestibular and oral sides. | day 0 (initial value)] |
| Attached mucosa measurement |
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Inclusion Criteria:
Non-inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russia |
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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| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| implantation | Procedure |
|
|
Evaluation of the width of the keratinized gum will be carried out using a periodontological probe. The width is measured between the mucosal-gingival junction between the vestibular and oral sides. |
| day 180 compared to the 0th day (initial value) |
| Evaluation of soft tissue aesthetics | Evaluation of soft tissue aesthetics will be carried out according to clinical examination data after the installation of the final orthopedic structure using standard PES (Pink esthetic score). points from 0 to 2, where "2" means a result close to natural. | day 180 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. points from 0 to 4, where "4" means the worst result | Day 0 (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. points from 0 to 4, where "4" means the worst result | Day 1 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. points from 0 to 4, where "4" means the worst result | Day 3 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. points from 0 to 4, where "4" means the worst result | Day 5 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. points from 0 to 4, where "4" means the worst result | 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. points from 0 to 4, where "4" means the worst result | Day 90 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. points from 0 to 4, where "4" means the worst result | Day 180 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 | 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 | 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 | 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 | 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 | Day 90 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) | Day 1 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) | 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) | 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) | 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 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. | 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. | 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. | 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 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 | 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 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 | Day 90 compared to the 0th day (initial value) |
| Operating time estimation | The operative time was measured using chronometry from the time of anesthetic administration to the last suture | Day 1 compared to the 0th day (initial value) |
| Implant Stability Quotient (ISQ) | The Implant Stability Quotient (ISQ) was measured using Pinguin device (Integration Diagnostics Sweden AB) | Day 1 compared to the 0th day (initial value) |
| Implant Stability Quotient (ISQ) | The Implant Stability Quotient(ISQ) was measured using Pinguin device (Integration Diagnostics Sweden AB) | Day 180 compared to the 0th day (initial value) |