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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
Clinica Dental Ortiz-Puigpelat
Barcelona, Spain
RECRUITINGAnalyze 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.
Time frame: 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.
Time frame: 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.
Time frame: At T12 (12 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) in milimeters.
Time frame: At T0(initial) before 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) in milimeters.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At T12 (12 months after the extraction)