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Completed

NCT Number: NCT04214041

Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

The aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

A total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria University. Ridge defects were divided into two parallel groups:

Test group: localized ridge defects were augmented using autologous fat grafting Control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation.
  • Teeth in the defect area have been extracted at least 3 months prior to enrolment
  • All patients were systemically healthy
  • Patients were non-smokers
  • Patients had abdominal fat accumulation allowing liposuction
  • Ability to understand the nature of the proposed surgery and ability to sign an informed consent form

Exclusion criteria

  • General contra-indications to surgical procedures
  • Pregnancy
  • Systemic diseases like Diabetes Mellitus and autoimmune diseases
  • History of malignancy, chemotherapy or radiotherapy within the last 5 years
  • Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Treatment and study plan

Autologous fat grafting

Other

A fat graft will be aspirated from the abdomen under local anaesthesia and processed using the Microfat grafting technique. Afterwards the fat graft will be injected in the previously created pouch at the recipient site. Then the pouch will be closed using interrupted sutures 5-0 vicryl.

Sub-epithelial connective tissue graft

Other

A subepithelial connective tissue graft of a size that corresponds to that of the defect will be harvested from the palate using the trap door technique. The donor site will be closed using cross horizontal sling sutures and interrupted sutures 4-0 vicryl. Subsequently, the graft will be inserted in the previously created pouch at the recipient site and secured to the flap using vicryl sutures 5-0. Then the pouch will be closed using interrupted sutures.

Primary outcomes

  1. Volumetric analysis to evaluate soft tissue volume changes

    Time frame: 1 month

    To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies

  2. Volumetric analysis to evaluate soft tissue volume changes

    Time frame: 2 months

    To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies

  3. Volumetric analysis to evaluate soft tissue volume changes

    Time frame: 3 months

    To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies

Secondary outcomes

  1. Probing depth

    Time frame: 1 month

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  2. Probing depth

    Time frame: 2 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  3. Probing depth

    Time frame: 3 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  4. Clinical attachment loss (CAL)

    Time frame: 1 month

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  5. Clinical attachment loss (CAL)

    Time frame: 2 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  6. Clinical attachment loss (CAL)

    Time frame: 3 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth

  7. Bleeding on probing

    Time frame: 1 month

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent

  8. Bleeding on probing

    Time frame: 2 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent

  9. Bleeding on probing

    Time frame: 3 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent

  10. Width of Keratinized tissue

    Time frame: 1 month

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line.

  11. Width of Keratinized tissue

    Time frame: 2 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line.

  12. Width of Keratinized tissue

    Time frame: 3 months

    measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Soft Tissue Volume Augmentation of Localized Horizontal Ridge Defects Using Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft (a Randomized Controlled Clinical Trial)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 30, 2019
Registry last updated
Dec 4, 2023

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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