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OpenTrials
Completed

NCT Number: NCT06609720

Randomized Clinical and Radiographic Study

Randomized clinical and radiographic trial

Completed

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry

Tanta, Egypt

About this study

Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-

Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.

  • Horizontal probing depth ≥3 mm using Naber's probe.
  • Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
  • Evidence of radiolucency in the furcation area on panoramic radiograph.
  • Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).

Exclusion criteria

  • Medically compromised patients and systemic conditions precluding periodontal surgery.
  • Mandibular first or second molars with root caries or endodontic treatment.
  • Smokers, diabetics, pregnant or lactating women.
  • History of chemotherapy, radiotherapy in head and/or neck region.
  • Bisphosphonate therapy.

Treatment and study plan

(guided tissue regeneration)

Procedure

Randomized clinical and radiographic trial

Primary outcomes

  1. Probing pocket depth

    Time frame: Measured at baseline, 6 months and 12 months

    According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.

  2. Clinical attachment level

    Time frame: Measured at baseline, 6 months and 12 months

    According to Ramfjord, clinical parameter measured by a Naber's probe. Using stent to standard measurements.

  3. Bleeding on probing

    Time frame: Measured at baseline, 6 months and 12 months

    According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.

Secondary outcomes

  1. Radiographic outcome

    Time frame: measured at baseline and 1 year follow up

    Using CBCT software to analyse furcation volume

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Autogenous Dentin Graft Versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

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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