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The One-piece Autologous Tuberosity Graft

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04356001
Enrollment
10
Registered
2020-04-21
Start date
2019-01-19
Completion date
2019-12-22
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

extraction, socket preservation, autologous, maxillary tuberosity, hard and soft tissue graft

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESocket preservation

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

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of volume of the ridge from baseline to 4 months post-op4 monthsVolumetric variation of the ridge, measured on superimposed images of CBCT.
Change of Vertical dimension of the ridge from baseline to 4 months post-op4 monthsLinear Vertical variation of the ridge, measured on superimposed images of CBCT.
Change of Horizontal dimension of the ridge from baseline to 4 months post-op4 monthsLinear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Change in Soft tissue from baseline to 4 months post-op4 monthsVariation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.

Secondary

MeasureTime frameDescription
Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)4 monthsThickness of the keratinized mucosa on the crestal site, measured with a gauge caliper.
Change in Hard tissue from baseline to 4 months post-op (clinical measurements)4 monthsHorizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe
Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)4 monthsThickness of the keratinized mucosa on the buccal site, measured with a gauge caliper.

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026