Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery

NCT06371430 | Completed DMC

• 1 other identifier: Biointelligent Technology Syst
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.

Conditions

Wound Healing Disorder; Wounds and Injuries; Wound Surgical

Keywords

Bone bioactive liquid; Dental implant; Oral wound healing

Outcome Measures

Primary Outcomes (1)

• ISQ measurements

  Implant stapelity

  3 month

Secondary Outcomes (1)

• CBCTs analysis

  2 month

Study Arms (3)

Pain Scale

PLACEBO COMPARATOR

To assess the efficacy of the surgical procedure, pain scale evaluations were conducted on day 1,4 and 7, following the surgery. This evaluation involved a direct contact with the patients to gauge their subjective pain experience. A modified visual analog scale (VAS) was utilized, as described in reference \[34\]. No pain scale = 0, moderate pain scale = 5 and maximum pain scale = 10 \[21\]. In addition to efficacy measurements, safety measurements were also considered. The occurrence of adverse events (AEs) and serious adverse events (SAEs) was monitored throughout the duration of the study. These events were either detected by the investigator or reported by the patients themselves. The aim was to identify any potential complications or issues that arose because of the surgical procedure.

Device: Dental Implant insertion and tooth extraction

RFA and ISQ measurements

PLACEBO COMPARATOR

After the implants were fully seated, a Smartpeg specific to the implant system and restorative platform diameter was used for each implant. RFA was then performed using an OsstellMentor device from Ostell/Integration Diagnostics in Gothenburg, Sweden. This analysis was used to measure the ISQ values for all implant surfaces at days 0, 7 and 30 post-surgeries. For each implant, 4 readings were taken per lingual, mesial, distal, and vestibular direction. The average ISQ values of all the readings were recorded. Following the RFA measurements, new sterile healing abutments were inserted, and the incisions were sutured to close the wounds.

Device: Dental Implant insertion and tooth extraction

CBCT analysis

EXPERIMENTAL

CBCTs were captured for implants from six patients with total of 24 implants, with 12 implants Galaxy TS (non-treated) on one side of the jaw and 12 implants Galaxy TSA (treated with BBL) on the other side of the jaw. All patients in this group had implants inserted in the upper jaw and each patient had 4 implants inserted (All on 4 technique). The CBCTs scans were conducted at days 1 and 60 post-surgeries using a 3D Accuitomo 170 scanner (J. MORITA EUROPE GMBH). The scans were performed with the following technical parameters: 90 kV, 5 mA, 87.5 mAs, voxel size ranging from 125-250 µm, 360° rotation, and scanning time of 17.5 s as previously described \[32\]. To ensure accuracy, a bite mark was utilized during CBCT scanning to correspond to the patients' midline. Consistency in bite mark placement was maintained to ensure that the same slice was obtained for each scan performed on the patient

Device: Dental Implant insertion and tooth extraction

Interventions

Dental Implant insertion and tooth extraction DEVICE

The osteotomies were carried out at a speed of 800 rpm, using sequential burs of similar diameter for both the maxilar and the mandibular side. The drilling protocols followed the recommendations provided by the manufacturer, the Galaxy-Ziacom implant system, for standard drilling. The insertion of the implants was initiated using a motor handpiece at a speed of 20-50 rpm, without irrigation. The installation process was completed using a manual surgical torque wrench indicator. The maximum torque value (Ncm) reached at the end of implant insertion was recorded as the insertion torque (IT). A total of 264 implants were inserted in 33 patients, 160 implants were post-extraction and 104 implants were inserted after at least one-month post-extraction. The sutures were typically removed 1 week after the surgery, during the postoperative follow-up appointment.

CBCT analysis; Pain Scale; RFA and ISQ measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• sufficient residual bone volume to accommodate implant placement without requiring bone augmentation, minimum ridge height and width of ≥ 9mm and ≥ 6mm, respectively, and healed bone sites with a minimum of 1 months of post-extraction healing.

You may not qualify if:

• Patients with alcoholism.
• Smoking habits.
• History of illicit drug use were excluded.
• Patients with heart diseases.
• Diabetes.
• Previous bone regenerative or augmentation procedures.
• Bleeding disorders.
• Compromised immune systems.
• History of radiation therapy
• Treatment with steroids or bisphosphonates

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead
• Universidad Pública de Navarra: collaborator
• Dasman Diabetes Institute: collaborator

Study Sites (1)

Biointelligent Technology Syst

Barcelona, 08009, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: April 14, 2021
• Primary Completion: June 14, 2022
• Study Completion: April 14, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

ES (1)