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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04816110
Enrollment
16
Registered
2021-03-25
Start date
2019-04-10
Completion date
2020-12-15
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss, Horizontal Alveolar Bone Defect

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.

Interventions

BIOLOGICALmineralized 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% + 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

BIOLOGICALmineralized 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% + 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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Painup to 1 weekThe visual analog scale was used to gauge the degree of post-operative pain with a scale from zero (lowest) to ten (highest)
Postoperative Edemaup to 1 weekA 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 depthup to 9 monthsProbing 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 stabilityup to 3 monthsThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026