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

Phase 2

• Conditions: Tooth extraction; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000190505
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-27
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified