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Clinical Trials/ACTRN12624000190505
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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