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

Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Missed Upper Posterior Teeth
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlya
    • Mansoura, Dakahlya, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- a) 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.

f) Patients free from any systemic disease

Exclusion Criteria:

• 1) Patients with systemic disease that prevent surgical intervention or bone healing.

  2) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	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.	3 months
Bleeding	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 months
Radiographic evaluation	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).	immediate postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant stability	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.	6 months
Bleeding	Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI).	6 months
Radiographic evaluation	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).	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2020
• Primary Completion (Actual): February 10, 2022
• Study Completion (Anticipated): November 10, 2022

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Autologous fibrin glue; Crestal sinus lift; Sticky bone
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: M02150620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No