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Completed

NCT Number: NCT04356001

The "One-piece" Autologous Tuberosity Graft

A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Joseph university

Beirut, 1104 2020, Lebanon

About this study

Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.

Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy patient
  • Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
  • No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
  • Non-smoker or Light Smoker < 10 cigarettes/day

Exclusion criteria

  • Pregnant or lactating females
  • Non-controlled periodontal disease
  • Medical conditions that contraindicate implant surgery
  • Metabolic bone disorders such as osteoporosis,..
  • Severe psychiatric conditions
  • Heavy smoker > 10 cigarettes/day

Treatment and study plan

Socket preservation

Procedure

'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.

Other names: autologous tuberosity graft

Primary outcomes

  1. Change of volume of the ridge from baseline to 4 months post-op

    Time frame: 4 months

    Volumetric variation of the ridge, measured on superimposed images of CBCT.

  2. Change of Vertical dimension of the ridge from baseline to 4 months post-op

    Time frame: 4 months

    Linear Vertical variation of the ridge, measured on superimposed images of CBCT.

  3. Change of Horizontal dimension of the ridge from baseline to 4 months post-op

    Time frame: 4 months

    Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.

  4. Change in Soft tissue from baseline to 4 months post-op

    Time frame: 4 months

    Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.

Secondary outcomes

  1. Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)

    Time frame: 4 months

    Thickness of the keratinized mucosa on the buccal site, measured with a gauge caliper.

  2. Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)

    Time frame: 4 months

    Thickness of the keratinized mucosa on the crestal site, measured with a gauge caliper.

  3. Change in Hard tissue from baseline to 4 months post-op (clinical measurements)

    Time frame: 4 months

    Horizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

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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