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

NCT04816110 | Completed Phase 2

• 1 other identifier: MPM & bone regeneration
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Horizontal Alveolar Bone Defect; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

mineralized plasmatic matrix with collagen membrane

EXPERIMENTAL

Biological: mineralized plasmatic matrix with collagen membrane

mineralized plasmatic matrix without collagen membrane

ACTIVE COMPARATOR

Biological: mineralized plasmatic matrix (MPM) without collagen membrane

Interventions

mineralized plasmatic matrix with collagen membrane BIOLOGICAL

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

mineralized plasmatic matrix with collagen membrane

mineralized plasmatic matrix (MPM) without collagen membrane BIOLOGICAL

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.

mineralized plasmatic matrix without collagen membrane

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with missing anterior maxillary teeth and having deficient alveolar thickness.
• Good oral hygiene
• Alveolar ridge width less than 4 mm.

You may not qualify if:

• Medically compromised patients.
• Heavy smokers.
• Current chemotherapy or radiotherapy

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

1-methyl-1-piperidinomethane sulfonate

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yomna M Abo Serie, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Moustafa El Dibany, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Gaafar N El Halawani, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and oral surgeon

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: April 10, 2019
• Primary Completion: September 10, 2020
• Study Completion: December 15, 2020
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

EG (1)