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NCT07748871
Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)
Conditions: Tooth Loss / Rehabilitation, Tooth Extraction, Alveolar Bone Loss, Alveolar Ridge Augmentation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Bern
Location: University of Bern, Department of Reconstructive Dentistry and Gerodontology Bern Canton of Bern
Summary
This randomized controlled trial compares two provisional socket-sealing concepts following single non-molar tooth extraction and alveolar ridge preservation: a fixed, tooth-supported, 3D-printed ovate pontic provisional restoration providing active soft tissue support (test) versus a removable Essix-type provisional restoration without intentional soft tissue contact combined with a porcine collagen matrix seal (control). Both groups receive alveolar ridge preservation using a deproteinized bovine bone mineral with 10% collagen. The primary endpoint is interproximal soft tissue height at 5 months, adjusted for baseline, assessed by digital superimposition of intraoral surface scans. Up to 40 participants will be enrolled at the University of Bern School of Dental Medicine.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older
* ASA physical status I or II
* Requiring a single non-molar tooth extraction (incisor, canine, or premolar) in the maxilla or mandible, with planned tooth replacement
* Extraction site bounded by natural, periodontally stable adjacent teeth
* Intact alveolar socket upon extraction, or no more than one bony wall (facial, palatal, or lingual) presenting a dehiscence extending less than 50% of the total bony wall height
* Willingness and ability to comply with the follow-up protocol
* Ability to give informed consent, as documented by signature
Exclusion Criteria:
* Current smokers, or former smokers who quit less than 6 months before extraction
* Uncontrolled diabetes mellitus (HbA1c \> 7.0%)
* Clinical attachment loss ≥ 2 mm at the extraction site
* Active or recent chemotherapy, or history of head and neck radiotherapy
* Current or previous bisphosphonate therapy within the past 10 years
* Immunosuppressive medication
* Active oral or systemic acute infection
* Severe hematologic disorder, hepatic or renal failure, or any clinically relevant bleeding disorder or anticoagulant medication that cannot be safely managed for the planned surgical procedure
* Pregnancy or lactation
* Known allergy or hypersensitivity to any of the study materials, including bovine-derived bone substitute, porcine-derived collagen matrix, or collagen-containing biomaterials
* Any other disease or medication that may compromise normal wound healing
* Inability to follow the study procedures (e.g., insufficient language comprehension, cognitive impairment, psychological disorder, or dementia)
* Known or suspected non-compliance
* Participation in another clinical trial that may interfere with the present study
Source: ClinicalTrials.gov (NCT07748871). StuddyBuddy aggregates publicly available trial information.