None listed
Conditions
Brief summary
Following a tooth extraction, the body responds and adapts the bone around the extraction site in its normal healing process. Inevitably, this results in a decrease in the amount of bone and gum tissue at the extraction site. Dental implants are reliant on bone to facilitate their placement and support the implant as it functions as a tooth replacement. As such, minimising bone loss after an extraction is key to optimise the success of implant placement. Bone grafting techniques are commonly used to assist the body in healing promoting the maximum preservation of bone. New materials are available which aim to stimulate the body’s healing ability when used in conjunction with a standard grafting material. This study aims to evaluate the effectiveness of using a biological stimulating product (a viscoelastic gel containing hyaluronic acid and polynucleotides) in conjunction with the grafting material to maximise the healing response after an extraction.
Interventions
To compare the clinical efficacy of a new biological agent Regenfast [viscoelastic gel containing hyaluronic acid (HA) and polynucleotides (PN)] into alveolar ridge preservation biomaterials: deproteinised bovine bone mineral with 10% collagen (DBBM-C) and collagen matrix into extraction sockets.
250mg of DBBM-C soaked in 0.6ml viscoelastic gel for 5 minutes prior to placement into a single extraction socket (single administration) in each participant. The product will be soaked and administere
To compare the clinical efficacy of a new biological agent Regenfast [viscoelastic gel containing hyaluronic acid (HA) and polynucleotides (PN)] into alveolar ridge preservation biomaterials: deproteinised bovine bone mineral with 10% collagen (DBBM-C) and collagen matrix into extraction sockets. 250mg of DBBM-C soaked in 0.6ml viscoelastic gel for 5 minutes prior to placement into a single extraction socket (single administration) in each participant. The product will be soaked and administered by the primary clinician (Periodontist- Dr, A,J-L)
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed