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

Primary Purpose

Horizontal Alveolar Bone Defect, Alveolar Bone Loss

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
mineralized plasmatic matrix with collagen membrane
mineralized plasmatic matrix (MPM) without collagen membrane
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Horizontal Alveolar Bone Defect

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mineralized plasmatic matrix with collagen membrane

mineralized plasmatic matrix without collagen membrane

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
March 23, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04816110
Brief Title
Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration
Official Title
Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horizontal Alveolar Bone Defect, Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mineralized plasmatic matrix with collagen membrane
Arm Type
Experimental
Arm Title
mineralized plasmatic matrix without collagen membrane
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
mineralized plasmatic matrix with collagen membrane
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
mineralized plasmatic matrix (MPM) without collagen membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
The visual analog scale was used to gauge the degree of post-operative pain with a scale from zero (lowest) to ten (highest)
Time Frame
up to 1 week
Title
Postoperative Edema
Description
A visual descriptor analogue scale was utilized to indicate presence/ absence of edema and inflammation with a scale of zero (lowest) to 5 (highest)
Time Frame
up to 1 week
Title
Peri-implant Probing depth
Description
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.
Time Frame
up to 9 months
Title
Implant stability
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna M Abo Serie, BDS
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moustafa El Dibany, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gaafar N El Halawani, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt

12. IPD Sharing Statement

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

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