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

Phase 2

Completed

• Conditions: Alveolar Bone Loss; Horizontal Alveolar Bone Defect
• Interventions: Biological: mineralized plasmatic matrix (MPM) without collagen membrane; Biological: mineralized plasmatic matrix with collagen membrane

• Registration Number: NCT04816110
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-10
• Primary Completion: 2020-09-10
• Study Completion: 2020-12-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mineralized plasmatic matrix without collagen membrane	mineralized plasmatic matrix (MPM) without collagen membrane	-
mineralized plasmatic matrix with collagen membrane	mineralized plasmatic matrix with collagen membrane	-

Primary Outcome Measures

Name	Time	Method
Peri-implant Probing depth	up to 9 months	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	up to 3 months	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.
Postoperative Pain	up to 1 week	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	up to 1 week	A visual descriptor analogue scale was utilized to indicate presence/ absence of edema and inflammation with a scale of zero (lowest) to 5 (highest)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt