ACTRN12624000190505Not yet recruitingPhase 2
The clinical effects of the adjunctive use of a viscoelastic gel containing hyaluronic acid and polynucleotides with deproteinised bovine bone mineral and collagen matrix in alveolar ridge preservation: A Pilot Randomised Controlled Clinical Trial
The University of Western Australia0 sites20 target enrollmentStarted: February 27, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 21 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Patient-specific inclusion criteria
- •Age greater than or equal to 21 years old
- •Females and Males
- •Systemic and local conditions compatible with implant placement and experimental procedures
- •Patient willing and fully capable of complying with the study protocol.
- •Tooth and site-specific inclusion criteria
- •To be considered the tooth site will have to fulfil all the following criteria:
- •Terminal prognosis of a single-rooted incisor, canine or premolar tooth requiring extraction.
- •Extraction may be indicated due to trauma, endodontic complication (root fracture) or unrestorable caries.
- •Periodontal status: adequate oral hygiene, Bleeding on probing <20%, Plaque index < 20%
- •Single tooth extraction with no missing adjacent teeth.
- •Accepted characteristics of an extraction socket site:
- •o Buccal socket wall with >50% of the buccal bone height is present.
- •o Sufficient space is required for implant placement.
Exclusion Criteria
- •Patient-specific exclusion criteria
- •Current heavy smoking (>10 cigarettes/day for >6 months prior to and at the time of the surgical procedure)
- •Patients with uncontrolled diabetes: defined as HbA1c >7.0
- •Severe hematologic disorders, such as haemophilia or leukemia
- •Liver or kidney failure
- •History of radiation therapy in the head and neck area
- •History of chemotherapy
- •Systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing
- •Past (within 6 months prior to enrolment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or osseous healing
- •Documented allergy to dental materials involved in the experimental protocol
- •Pregnancy or lactation
- •Chronic drug abuse
- •Psychological disorders: mental disabilities that may interfere with reading, understanding and signing the informed consent and/or with following study-related instructions.
- •Moreover, participants immediately exited the study upon:
- •Request to withdraw from further participation
- •Development of acute dental, peri-implant or oral conditions requiring treatment
- •Development of conditions conflicting with the inclusion criteria listed above.
- •Failure to comply with study instructions/requirements.
- •Site-specific exclusion criteria:
- •Missing adjacent teeth
- •Buccal socket wall with more than 3mm or 25% of the coronal mid-buccal vertical wall lost.
- •Site with acute infection (i.e pain or presence of abscess).
Investigators
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