Alveolar Ridge Preservation Procedures

Study Overview
=================
Brief Summary
-----------------
Tooth loss is accompanied by different patterns of bone loss. Up to 50% loss of alveolar crestal bone width will likely occur 1 year after tooth loss, especially in the anterior maxilla. A great percentage of the process of alveolar bone resorption occurs within the first 3 to 6 months post-extraction. If ridge preservation is not conducted, 40%-60% of the total alveolar bone volume is lost during the first 2-3 years post-extraction, and this phenomenon has shown to continue to occur at a rate of 0.25%-0.5% loss per year. It has been proposed that ridge augmentation procedures may reduce the expected ridge reduction after tooth loss. Ridge augmentation procedures may require the use of bone grafts and non-resorbable or non-resorbable barrier membranes. The use of non-resorbable barrier membranes for ridge augmentation has the clinical disadvantage of needing a second procedure for its removal during the healing phase. Osteogen® plug (OPP) consists of a non-ceramic bone graft incorporated in type I bovine Achilles tendon collagen. OPP was first developed to serve as a one-step grafting solution for ridge preservation without the need for a barrier membrane

Detailed Description
-----------------
There will be two(2) groups of standardized treatment (tooth extractions will not take place for research purposes. The Periodontal clinic receives referred tooth extraction indications for treatment as part of the patient's overall treatment plan) evaluated for this study. Subjects will be randomized to either treatment a) standard of care treatment for tooth extraction and ridge augmentation procedures with Cytoplast GRB, or b) standard of the care treatment protocol and ridge augmentation procedures with Osteogen. Each individual extraction site of the enrolled subject will be randomly assigned to Group A and/or Group B for the ridge augmentation procedure. It is possible for a subject to be randomized to both treatment groups. Randomization is like a coin toss prior to the initiation of the surgical procedure. The coin toss will be to define the procedure to be conducted for the smallest tooth number first. A computer-generated randomization assignment has been populated for the ridge augmentation assignments. The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation.The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to one of two(2) ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area. Excess tissue will be collected if the subject has a standard of care implant-related procedure where tissue could need to be removed for implant placement purposes. For example, if a patient undergoes a tooth extraction, ridge augmentation, and implant placement then any portion of the excised tooth and connective tissue will be kept for later analyses of histology discovery. No additional tissue will be collected for research purposes. There will be one screening visit, a treatment visit, and 7 post-operative follow-up visits at 1, 2, 3, 4, 6, 8, and 20 weeks. Subjects will visit the clinic a total of eight (9) times. Of the 9 visits, 1 visit is standard of care, 3 visits are a combined standard of care and research procedure visits and 5 are strictly for research purposes. The nonabsorbable membranes in the control will be removed after 4-6 weeks in a most atraumatic manner with the help of a tweezer without disturbing the underlying new connective tissue formation. As there is no need for removal of the absorbable membrane in the experimental group.

Official Title
-----------------
Clinical Evaluation Of Soft Tissue Closure In Alveolar Ridge Preservation Procedures

Conditions
-----------------
Alveolar Ridge Preservation

Intervention / Treatment
-----------------
* Device: Osteogen plug®
* Device: MInerOss®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UT Clinic Participates Participates that live within 100 miles of UTHSC. Participates at least 12 years of age. If participants are 13-14 years of age, the premolars and molars will be included in this study. #2-15 & #18-31. Participates willing to cooperate with the post-operative instructions; Participates with 2 or more (multiples of 2) teeth needing Maxillary/mandibular and anterior/posterior teeth extractions without restrictions due to the percentage of surface area after the extraction and not interfering with the tooth's alveolar soft tissue exposed surface area. Participates with the availability of returning for 8 visits for data collection. Participants are willing to cooperate with answering the VAS and taking standardized photographs. Participants are physically able to tolerate surgical procedures based on current medical history. Participates able to provide voluntary consent; read and understand English Exclusion Criteria: Participates with Diabetes History of use of bisphosphonates Current smoker If the participant is 12-13 years of age, the tooth/teeth to be removed will not be a primary tooth due to the permanent teeth developing underneath the primary teeth. Pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (Osteogen plug®)<br>The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation. The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to receive treatment with a type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)(Osteogen) ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area. | Device: Osteogen plug®<br>* A type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)<br>|
| Group B ( MInerOss® )<br>The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation. The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to a cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 4-6 weeks and again at 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area. | Device: MInerOss®<br>* A cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Bone Formation Changes | histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone | 4 weeks | 
| Histological Bone Formation Changes | histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone | 6 weeks | 
| Histological Bone Formation Changes | histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone | 20 weeks | 
| Clinical Dimensional Changes | Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0. | 4 weeks | 
| Clinical Dimensional Changes | Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0. | 6 weeks | 
| Clinical Dimensional Changes | Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography. Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0. | 20 weeks | 
| Evaluate Patient Pain | Evaluate patient pain during the wound healing phase using the visual analog scale (VAS). Scale range (0-10) : 0 1 2 3 4 5 6 7 8 9 10 Minimum Value: 0 = no pain Maximum Value: 10 = worse pain ever imaged | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone, OsteoGen, Cortico-Cancellous, Foreign body reaction