Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.

Study Overview
=================
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.

Official Title
-----------------
Effect of a Volumetrically Stable Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Post-extraction Implants: a Randomized Controlled Clinical Study.

Conditions
-----------------
Xenograft Model

Intervention / Treatment
-----------------
* Device: Xenogenic collagen matrix
* Device: Autogenous connective tissue graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adequate oral hygiene (21). Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion. Presence of adjacent teeth. Only one tooth gap. Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007 Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT). Exclusion Criteria: Patients with medical conditions that affect bone and soft tissue metabolism. Uncontrolled endocrine disorders. Alcohol and drug abuse. Previous history of immunodeficiency syndromes. Patients who smoke> 10 cigarettes a day. Active periodontal disease. Absence of a tooth adjacent to the tooth to be treated. Oral lesions of the untreated mucosa. Recent previous history (<6 months) of local radiotherapy or chemotherapy. Bruxism or severe parafunctions. Pregnant patients.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenogenic collagen matrix<br>Volumetrically stable xenogenic collagen matrix | Device: Xenogenic collagen matrix<br>* Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.<br>|
| Active Comparator: Autogenous connective tissue graft<br>Autogenous connective tissue graft obtained from the tuberosity area | Device: Autogenous connective tissue graft<br>* Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate dental implants, dental extraction, alveolar socket, connective tissue graft, xenogenic collagen matrix