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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04816110
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.2
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Horizontal Alveolar Bone Defect; Alveolar Bone Loss	Biological: mineralized plasmatic matrix with collagen membrane; Biological: mineralized plasmatic matrix (MPM) without collagen membrane	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Periimplant Bone Regeneration (Randomized Clinical Trial)
• Actual Study Start Date: Apr 10, 2019
• Actual Primary Completion Date: Sep 10, 2020
• Actual Study Completion Date: Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mineralized plasmatic matrix with collagen membrane	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% + 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
Active Comparator: mineralized plasmatic matrix without collagen membrane	Biological: 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% + 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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21527

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Yomna M Abo Serie, BDS, Faculty of Dentistry, Alexandria University, Egypt
• Study Director: Moustafa El Dibany, PhD, Faculty of Dentistry, Alexandria University, Egypt
• Study Director: Gaafar N El Halawani, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Youmna Aboserie, Primary Investigator and oral surgeon, Alexandria University
• ClinicalTrials.gov Identifier: NCT04816110
• Other Study ID Numbers: MPM & bone regeneration
• First Posted: Mar 25, 2021
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alveolar Bone Loss

Study Results

No Results Posted as of Mar 25, 2021