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| Name | Class |
|---|---|
| PerioCentrum Research | OTHER |
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This is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.
Nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa.
Therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis.
The hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent KT mucosa.
A sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed.
Peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. Also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular collagen matrix | Experimental | In a test group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Acellular collagen matrix will be adapted and suture to the vascular bed. |
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| Autogenous free gingival graft | Active Comparator | In a control group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Free gingival graft will be harvested from the zone of the posterior palate, and then adapted and sutured to the vascular bed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular collagen matrix | Other | 3D collagen matrix consists of the collagen porcine type I and III |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in width of keratinized peri-implant mucosa | Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing | Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks |
| Probing depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myroslav Solonko, DDS | Contact | 34684354549 | msolonko@gmail.com | |
| Alberto Ortiz-Vigón, PhD | Contact | 34 629 755 893 | alberto@ortizvigon.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Univesity Complutense, Madrid | Recruiting | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Multi-centre randomized clinical trial (2 centres) with the duration of 102 weeks for the evaluation of efficiency on the new collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis
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The examiners will be blinded. Envelopes will be prepared by a research assistant not involved as clinician or examiner. The clinicians involved will have no access to the data collection sheets or the group allocation, whilst the examiners will have no access to the patients' treatment notes or group allocation. The examiners will be blinded with regards to the participant treatment assignments. The measures will include no access to the dental records as to which treatment has been assigned. The patients are not to reveal their treatment assignment to the examiners. Unblinding is expected when patients present with adverse outcomes during the course of the study, e.g., emphysema.
| Autogenous free gingival graft | Other | Autogenous graft harvested from the posterior palate |
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Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the mucosal margin to the bottom of the peri-implant pocket
| Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks |
| Recession | Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the implant platform to the mucosal margin | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks |
| General satisfaction by the treatment | Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100 | 0, 1, 2, 4, 12, 26 and 52 weeks |
| Duration of surgery | Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture | after completion of surgical intervention |
| Vestibulum depth | Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks |