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Completed

NCT Number: NCT04514991

Bone Regenerative Techniques in Endodontic Microsurgery

The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPenn

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult.
  • Intact coronal restoration with no sign of leakage.
  • Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)

Exclusion criteria

  • Patients with medical conditions and contraindications to surgery.
  • Minors.
  • Pregnancy.
  • Teeth with signs of coronal leakage.
  • Teeth with vertical root fractures.

Treatment and study plan

Foundation

Device

Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.

Primary outcomes

  1. 2D Radiographic Healing at 12 Months Follow up (Overall Cases)

    Time frame: 12 months

    Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.

  2. 3D Radiographic Healing at 12 Months Follow up (Overall Cases)

    Time frame: 12 months

    Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing.

  3. 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)

    Time frame: 12 months

    Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.

  4. 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)

    Time frame: 12 months

    Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing

Secondary outcomes

  1. C Score (Overall Cases)

    Time frame: 12 months

    Cortical plate healing using RAC/B index as evaluated on CBCT scans.

    Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).

  2. C Score (Asymptomatic Cases Only)

    Time frame: 12 months

    Cortical plate healing using RAC/B index as evaluated on CBCT scans.

    Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2020
Registry last updated
Nov 21, 2022

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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