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

ConditionsPartially Edentulous Maxilla Partially Edentulous Mandible

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: "Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface)Experimental treatment 1 intervention

Group B: "Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame