Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration

Study Overview
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Brief Summary
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This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone.

Official Title
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Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)

Conditions
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Horizontal Alveolar Bone Defect, Alveolar Bone Loss

Intervention / Treatment
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* Biological: mineralized plasmatic matrix with collagen membrane
* Biological: mineralized plasmatic matrix (MPM) without collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with missing anterior maxillary teeth and having deficient alveolar thickness. Good oral hygiene Alveolar ridge width less than 4 mm. Exclusion Criteria: Medically compromised patients. Heavy smokers. Current chemotherapy or radiotherapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mineralized plasmatic matrix with collagen membrane<br> | Biological: mineralized plasmatic matrix with collagen membrane<br>* Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers: A yellow plasma liquid on the top of the tube. Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM. After implant placement, the buccal bone defect was grafted with MPM and covered by collagen membrane<br>|
| Active Comparator: mineralized plasmatic matrix without collagen membrane<br> | Biological: mineralized plasmatic matrix (MPM) without collagen membrane<br>* Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers: A yellow plasma liquid on the top of the tube. Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM. After implant placement, the buccal bone defect was grafted with MPM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | The visual analog scale was used to gauge the degree of post-operative pain with a scale from zero (lowest) to ten (highest) | up to 1 week | 
| Postoperative Edema | A visual descriptor analogue scale was utilized to indicate presence/ absence of edema and inflammation with a scale of zero (lowest) to 5 (highest) | up to 1 week | 
| Peri-implant Probing depth | Probing depth refers to the distance between the gingival margin and the bottom of the pocket. Mesial and distal pockets were measured as close as possible to contact points from the buccal aspect while facial and lingual pockets were measured at the midline of the implant. To prevent excessive tissue damage and over extension into the healthy tissue, the peri-implant sulcus depth was made with light force. | up to 9 months | 
| Implant stability | The implant stability was measured by Osstell®.The stability was evaluated on buccal, palatal, mesial and distal sides of the implant and the mean values of implant stability quotients ISQs were calculated. SQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability. | up to 3 months |