Xenograft Model
Conditions
Keywords
immediate dental implants, dental extraction, alveolar socket, connective tissue graft, xenogenic collagen matrix
Brief summary
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.
Interventions
Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
DEVICEAutogenous connective tissue graft
Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
Sponsors
Geistlich Pharma AG
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adequate oral hygiene (21). 2. Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion. 3. Presence of adjacent teeth. Only one tooth gap. 4. Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007 5. Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).
Exclusion criteria
1. Patients with medical conditions that affect bone and soft tissue metabolism. 2. Uncontrolled endocrine disorders. 3. Alcohol and drug abuse. 4. Previous history of immunodeficiency syndromes. 5. Patients who smoke\> 10 cigarettes a day. 6. Active periodontal disease. 7. Absence of a tooth adjacent to the tooth to be treated. 8. Oral lesions of the untreated mucosa. 9. Recent previous history (\<6 months) of local radiotherapy or chemotherapy. 10. Bruxism or severe parafunctions. 11. Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze the volumetric dimensional changes between the test and the control group | At T0(initial) before extraction | Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the band of keratinized tissue around the treated tooth | At T0(initial) before extraction | Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters. |
| Assessment of pain during surgery in both groups | At the day of the surgery | 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. |
| Quantification of the analgesic medication intake by patients in both groups | At 10 days after the surgery. | 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 |
| Comparison of the total surgical time used in each group. | At the day of the surgery | Measure the time needed for the suergery express in: hh/mm/ss |
| Analyze the mid-vestibular gingival level of the treated tooth. | At T0(initial) before extraction | 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. |
| Analyze patient satisfaction between groups | At T0 before extraction. | Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions. |
| Analysis of possible complications in both groups. | They will be reported anytime during the study | Record the number of complications and also a descriptive analysis of the different types of complications. |
| Evaluation of implant success in both groups at one year of follow-up | At T12 (12 months after the extraction) | Evaluation of implant success in both groups at one year of follow-up, expressed in the difference in milimeters of the periimplant bone loss. |
| 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. | 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. Expressed in € per each surgery. |
Countries
Spain
Contacts
Primary ContactOctavi Ortiz-Puigpelat, DDS, PhD
Outcome results
None listed