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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816110
• Other study ID #: MPM & bone regeneration
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 15, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Horizontal Alveolar Bone Defect

Intervention

Biological:
• mineralized plasmatic matrix with collagen membrane
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% + ß-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
• mineralized plasmatic matrix (MPM) without collagen membrane
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% + ß-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM. After implant placement, the buccal bone defect was grafted with MPM.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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