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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05613335
Enrollment
10
Registered
2022-11-14
Start date
2020-10-18
Completion date
2022-11-10
Last updated
2022-11-14

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

Conditions

Missed Upper Posterior Teeth

Keywords

Crestal sinus lift, Autologous fibrin glue, Sticky bone

Brief summary

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

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.

Interventions

PROCEDUREMaxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement

Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement

PROCEDUREMaxillary 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Implant stability3 monthsimplant 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.
Bleeding3 monthsPeri-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.
Radiographic evaluationimmediate postoperativeCone 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

MeasureTime frameDescription
implant stability6 monthsimplant 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.
Bleeding6 monthsPeri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI).
Radiographic evaluation6 monthsCone 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).

Countries

Egypt

Outcome results

None listed

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