Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone With Simultaneous Implant Insertion.

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05613335
Collaborator
(none)
10
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2
24.7
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Study Details

Study Description

Brief Summary

prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement
  • Procedure: Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement
N/A

Detailed Description

The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study
Actual Study Start Date :
Oct 18, 2020
Actual Primary Completion Date :
Feb 10, 2022
Anticipated Study Completion Date :
Nov 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: fibrin glue group

Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement

Procedure: Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement
Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement

Experimental: sticky bone group

Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement

Procedure: Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement
Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement

Outcome Measures

Primary Outcome Measures

  1. Implant stability [3 months]

    implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability. 6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.

  2. Bleeding [3 months]

    Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI). Score 0; no bleeding when a periodontal probe was passed along the gingival margin adjacent to the implant. Score 1; isolated bleeding visible spot. Score 2; a confluent red line on the gingival margin was formed by blood. Score 3; heavy or profuse bleeding is present.

  3. Radiographic evaluation [immediate postoperative]

    Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site. Implant protrusion (IP):measured as the distance from the sinus floor to implant apex. Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor). Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).

Secondary Outcome Measures

  1. implant stability [6 months]

    implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability. 6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.

  2. Bleeding [6 months]

    Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI).

  3. Radiographic evaluation [6 months]

    Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site. Implant protrusion (IP):measured as the distance from the sinus floor to implant apex. Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor). Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.
  1. Patients free from any systemic disease
Exclusion Criteria:
    1. Patients with systemic disease that prevent surgical intervention or bone healing.
  1. Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Mansoura Dakahlya Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05613335
Other Study ID Numbers:
  • M02150620
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mansoura University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022