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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenogenic collagen matrix | Experimental | Volumetrically stable xenogenic collagen matrix |
|
| Autogenous connective tissue graft | Active Comparator | Autogenous connective tissue graft obtained from the tuberosity area |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenogenic collagen matrix | Device | Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Analyze the volumetric dimensional changes between the test and the control group | Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3. | At T0(initial) before extraction |
| Analyze the volumetric dimensional changes between the test and the control group | Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3. | At T6 (6 months after extraction) |
| Analyze the volumetric dimensional changes between the test and the control group | Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3. | At T12 (12 months after extraction). |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the mid-vestibular gingival level of the treated tooth. | Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters. | At T0(initial) before extraction |
| Analyze the mid-vestibular gingival level of the treated tooth. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Octavi Ortiz-Puigpelat, DDS, PhD | Contact | +34629831138 | octaviortiz@uic.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dental Ortiz-Puigpelat | Recruiting | Barcelona | 08028 | Spain |
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| Autogenous connective tissue graft | Device | Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets. |
|
Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters. |
| At T6 (6 months after extraction) |
| Analyze the mid-vestibular gingival level of the treated tooth. | Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) with the use of periodontal probe in milimeters. | At T12 (12 months after extraction). |
| Measure the band of keratinized tissue around the treated tooth | Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters. | At T0(initial) before extraction |
| Measure the band of keratinized tissue around the treated tooth | Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters. | At T6 (6 months after extraction) |
| Measure the band of keratinized tissue around the treated tooth | Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters. | At T12 (12 months after extraction). |
| Assessment of pain during surgery in both groups | Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain. | At the day of the surgery |
| Assessment of pain during surgery in both groups | Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain. | After 10 days after surgery |
| Quantification of the analgesic medication intake by patients in both groups | Quantification of the analgesic medication intake by patients in both groups after 10 days of the surgery. Type of analgesic/antiinflmatory medication and number of pills/day | At 10 days after the surgery. |
| Comparison of the total surgical time used in each group. | Measure the time needed for the suergery express in: hh/mm/ss | At the day of the surgery |
| Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application. | Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application. Expressed in € per each surgery. | At the day of the surgery |
| Analyze patient satisfaction between groups | Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions. | At T0 before extraction. |
| Analyze patient satisfaction between groups | Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions. | At T12 (12 months after the extraction). |
| Analysis of possible complications in both groups. | Record the number of complications and also a descriptive analysis of the different types of complications. | They will be reported anytime during the study |
| Evaluation of implant success in both groups at one year of follow-up | Evaluation of implant success in both groups at one year of follow-up, expressed in the difference in milimeters of the periimplant bone loss. | At T12 (12 months after the extraction) |