Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants

NCT06460103 | Not Yet Recruiting

• 1 other identifier: AP2022-06
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although bone grafting at the same time as the placement of dental implants is a common procedure in implantology, there are currently no data on the influence of different types of implant surfaces on bone healing, which is crucial for implant stability. The primary objective of this study is to assess if implant surface properties, i.e. hydrophilicity, affect the osseointegration of the implant in simultaneously augmented bone. The secondary objective is to assess if implant surface properties, i.e. surface hydrophilicity, may affect the quantity of newly formed bone in the implant in simultaneously augmented bone. Surface hydrophilicity modification is a well-adapted concept in dental implantology and is clinically well-established. In this prospective study, all participants will receive a bone graft after extraction. After randomization, one group will receive a provisional SLA surface implant and another group will receive a provisional SLActive surface implant. The same standard surgical procedure will be performed for both groups when the definitive implant will be placed. The study will run for a total of 3 year, and 35 patients per group will be included. The Straumann SLA and SLActive implants, Maxgraft allograft and collprotect collagen membranes used in this study are all approved products on the Swiss market.

Conditions

Partially Edentulous Maxilla; Partially Edentulous Mandible

Keywords

Dental implants; SLActive; Hydrophile surface

Outcome Measures

Primary Outcomes (1)

• Bone-to-Implant Contact (BIC)

  The cross-sectional implant perimeter percentage in direct contact with newly formed bone over the total cross-sectional implant perimeter. Only the perimeter in contact with augmented bone will be considered for measuring this parameter.

  3 weeks after implant placement

Secondary Outcomes (4)

• Percentage of newly formed bone area

  3 weeks after implant placement

• Graft particle area

  3 weeks after implant placement

• Assessment of the tissue inflammatory response

  3 weeks after implant placement

• Assessment of the healing response

  3 weeks after implant placement

Study Arms (2)

"Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface)

EXPERIMENTAL

Tooth extraction + "Straumann® Bone Level Tapered, SLActive®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane")

Device: Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)

"Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface)

ACTIVE COMPARATOR

Tooth extraction + "Straumann® Bone Level Tapered , SLA®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane")

Device: Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)

Interventions

Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface) DEVICE

Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLActive®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.

"Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface)

Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface) DEVICE

Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLA®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.

"Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 18 years
• Patients with a diagnosed indication for single tooth extraction and scheduled for consented replacement by an implant-based restoration requiring prior bone augmentation
• Only patients displaying periodontally healthy teeth adjacent to the extracted teeth shall be included (probing depth (PD) \< 4mm, no bleeding on probing (BOP)
• Patients must be physically and psychologically able to undergo implant surgery and restorative procedures (American Academy of Anesthesiologist class I or II)

You may not qualify if:

• Presence of any general contra-indication related to implant therapy
• Heavy smokers ( ≥10 cigarettes/day)
• Patients displaying a history of uncontrolled metabolic disorders (e.g. diabetes mellitus)
• Patients with a history of malignancy, radiotherapy, or chemotherapy
• Pregnant or breast feeding patients
• Patients with a history of immunodeficiencies
• Patients displaying any metabolic bone disease
• Patients with disturbed bone or wound healing
• Patients with untreated or active periodontitis (BOP and PD\>5mm)
• Extraction sites displaying an absent or defections buccal bone plate
• Vulnerable patients will be excluded from the study.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Officials

• Alexandre Perez, Dr

  University of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Perez, Dr

CONTACT

+4179 553 50 41; alexandre.perez@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Treatment blinding will not be possible as both device types, i.e. test and control implants, can be easily visually differentiated during handling and implantation. Test and control groups will be blinded for evaluation and statistical analysis and performed by independent laboratories.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oral surgery and implantology unit

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 14, 2024

Record last verified: 2024-06