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Enrolling by Invitation

NCT Number: NCT06099431

Mandibular Reconstruction Bone Plate

The purpose of this study is to evaluate the reliability of using mandibular osteosynthesis a 2.3mm reconstruction bone plate in the maintenance of the space, contour, and mandibular bone preservation during marginal mandibular resection.

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Key information

Conditions

Mandible Tumor Bone Diseases Bone Neoplasms Jaw Diseases Jaw Neoplasms Mandibular Diseases Mandibular Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Skull Neoplasms Stomatognathic Diseases

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 3111, Egypt

About this study

This prospective study included 16 patients (n=16) suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection.

Patient history included personal data (name, age, sex, and occupation), date of lesion discovery, mode of growth (rapid or slow), and symptoms (e.g. pain and/or ipsilateral paresthesia of the lower lip).

Clinical examination included the site and extent of mandibular bony expansion and covering soft tissues (normal, ulcerated from indentation of opposing teeth, or scarred due to previous incisional biopsy).

Radiographical examination involved orthopantomography (OPG) and axial and coronal computed tomography (CT) scans to assess the lesion extensions.

All patients are operated under general anesthesia which was induced by intravenous access. Intubation is routinely performed in nasoendotracheal fashion.

Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins are carried out around the teeth to be included in the resection.

The plastic template is adapted to the buccal cortex of the mandible to aid in the final adaptation of a 2.3 mm reconstruction bone plate (Antonhib, Germany). The osteotomy lines are marked using a long shank surgical tapered fissure bur. a 2.3 mm reconstruction bone plate is then fit in place and fixed to both the proximal and distal segments then removed. The osteotomies completed and the resected segment is removed, and the reconstruction plate is then replaced by the aid of screw holes in both the proximal and distal segments. The intraoral wound is carefully closed in double layers using a combination of interrupted and horizontal mattress resorbable 3/0 sutures.

post operative follow up clinically regarding soft tissue healing, pain, infection, and plate exposure or plate fracture. Radiographically, Panoramic radiographs are taken immediately and axial and coronal computed tomography at six months post-operatively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection

Exclusion criteria

  • systemic disease affect primary wound healing malignancy

Treatment and study plan

Mandibular marginal resection and reconstruction

Procedure

Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins were carried out around the teeth to be included in the resection. The osteotomy lines were marked using a long shank surgical tapered fissure bur. The osteotomies completed and the resected segment was removed.

mandibular osteosynthesis a 2.3mm reconstruction bone plate

Device

a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments

Primary outcomes

  1. Degree of pain

    Time frame: 1 month

    The degree of pain is determined during the follow up periods according the scale of Kerkmanov and Nordenram , Mild: require one tablet of analgesics three times/ day, Moderate: require two tablets of analgesics three times/ day, Severe: require injective analgesics.

  2. Rate of inflammation

    Time frame: 1 month

    The wounds were inspected accurately post-operatively for detecting the proper healing using inflammation score scale, 0 no inflammation,1-3 mild inflammation, 4-7,moderate inflammation, 8-10 sever inflammation

  3. Rate of Infection

    Time frame: 6 months

    using Infection score scale , mild infection which responds to antibiotics, only without the need for incision and drainage, moderate infection which needs for incision and drainage and severe infection which needs for incision and drainage in addition to hardware removal.

Secondary outcomes

  1. Axial and coronal computed tomography

    Time frame: 6 month

    Degree of bone plate stability

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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