Biphasic Material With PRF in Lateral Sinus Floor Augmentation

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06071416

Collaborator

(none)

Enrollment

Arms

5.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment.

The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability.

The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.

Condition or Disease	Intervention/Treatment	Phase
Maxillary Sinus Disease	Procedure: Lateral sinus floor augmentation Drug: Biphasic Calcium Phosphate Procedure: Injectable platlets rich fibrin	Phase 1

Detailed Description

Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP.

platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

using automated sequence generation ( randomizer. org) patients will be divided into the two groups ,In sequentially numbered , opaque, sealed envelopes, participants will be enrolled and evaluated while the allocation sequence will be kept a secret from the researchers.

Primary Purpose:

Treatment

Official Title:

The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Mar 15, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 BCP alone Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application	Procedure: Lateral sinus floor augmentation maxillary sinus floor augmentation by lateral approach Drug: Biphasic Calcium Phosphate appliaction of BCP bone substitute
Active Comparator: Group 2 BCP with I-PRF Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF	Procedure: Lateral sinus floor augmentation maxillary sinus floor augmentation by lateral approach Drug: Biphasic Calcium Phosphate appliaction of BCP bone substitute Procedure: Injectable platlets rich fibrin centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute

Arm

Intervention/Treatment

Active Comparator: Group 1 BCP alone

Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application

Procedure: Lateral sinus floor augmentation

maxillary sinus floor augmentation by lateral approach

Drug: Biphasic Calcium Phosphate

appliaction of BCP bone substitute

Active Comparator: Group 2 BCP with I-PRF

Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF

Procedure: Lateral sinus floor augmentation

maxillary sinus floor augmentation by lateral approach

Drug: Biphasic Calcium Phosphate

appliaction of BCP bone substitute

Procedure: Injectable platlets rich fibrin

centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute

Outcome Measures

Primary Outcome Measures

Vertical bone gain BG [6 months]
Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Residual bone crest height < 5 mm and width≥6 mm in the planned implant site.
Healed bone crest (at least 6 months elapsed from tooth loss/extraction);

Exclusion Criteria:

Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alzahraa Alghriany, Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry, Assiut University

ClinicalTrials.gov Identifier:

NCT06071416

Other Study ID Numbers:

PRF in sinus augmentation

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alzahraa Alghriany, Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry, Assiut University

sinus floor augmentation

biphasic calcium phosphate

PRF

Additional relevant MeSH terms:

Paranasal Sinus Diseases

Calcium

Study Results

No Results Posted as of Oct 10, 2023