NCT07604142

Brief Summary

13 patients will be included in this study with a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus. after extraction, The prefabricated allogenic scaffold will be seated. then 6 months later, implant will be inserted.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Sep 2025Nov 2026

Study Start

First participant enrolled

September 20, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Tooth Loss

Keywords

CAD-CAM allogenic blockoroantral communicationradiographic analysishistological analysis

Outcome Measures

Primary Outcomes (2)

  • the integration of graft

    CBCT

    6 months

  • histological analysis of graft

    histomorphometric analysis

    6 months

Study Arms (1)

a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images re

EXPERIMENTAL

a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus. Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit. After removal of tooth, oro-antral communication will be verified .The prefabricated scaffold will be seated and covered with nonporous d-PTFE membrane. after 6 months, a bone biopsy will be taken using a trephine bur. Under strictly aseptic circumstances, the selected implant will be inserted.

Device: Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit

Interventions

Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kitDEVICE

Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit. After removal of tooth, oro-antral communication will be verified .The prefabricated CAD-CAM Allogenic bone will be seated and covered with nonporous d-PTFE membrane

a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images re

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 20 badly destructed upper molar indicated for extraction CBCT revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus

You may not qualify if:

  • any systemic disesse affect healing heavy smoker sinus disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Tanta, 3111, Egypt

Location

MeSH Terms

Conditions

Tooth LossOroantral Fistula

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesOral FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • mohamed helal, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

  • rehab ghouraba, professor

    Tanta University

    PRINCIPAL INVESTIGATOR

  • aya alsherif, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

September 20, 2025

Primary Completion (Estimated)

October 25, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

EG(1)