Multi-Evaluation of Dental Abutments With Different Surfaces

Condition(s) studied

Investigational drug(s) / intervention(s)

Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC: All implant surgeries will be performed under local anesthesia. A midcrestal incision will be made with a 15C blade, followed by careful elevation of a full-thickness flap. Implant insertion will be carried out according to the manufacturer's instructions, and a Nobel TiUltra™ implant will be placed 0.5-1 mm subcrestally. Following implant placement, primary implant stability will be measured using the Osstell device. Non-engaging temporary abutment will be placed for fabrication of the temporary fixed prosthesis, which will be constructed approximately 1 mm infraocclusally. The flap will be closed primarily. After 12 weeks, the temporary prosthesis will be removed and secondary implant stability will be assessed with an Osstell device. Impressions will be taken at the abutment level, and a permanent metal-supported porcelain fixed prosthesis will be fabricated and screwed onto the Multi-unit Abutments Xeal™ with a torque of 15 Ncm.

Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC: All implant surgeries will be performed under local anesthesia. A midcrestal incision will be made with a 15C blade, followed by careful elevation of a full-thickness flap. Implant insertion will be carried out according to the manufacturer's instructions, and a Nobel TiUltra™ implant will be placed 0.5-1 mm subcrestally. Following implant placement, primary implant stability will be measured using the Osstell device. Non-engaging temporary abutment will be placed for fabrication of the temporary fixed prosthesis, which will be constructed approximately 1 mm infraocclusally. The flap will be closed primarily. After 12 weeks, the temporary prosthesis will be removed and secondary implant stability will be assessed with an Osstell device. Impressions will be taken at the abutment level, and a permanent metal-supported porcelain fixed prosthesis will be fabricated and screwed onto the Conventional titanium multi-unit abutments with a torque of 15 Ncm.

Study summary

The placement of dental implants has been a routine procedure for the rehabilitation of fully or partially edentulous patients for nearly 40 years. Dental abutments are intermediary components that connect prosthetic teeth to the implants after healing. Depending on the properties of the abutment material, plaque accumulation and bacterial adhesion may lead to inflammation and bone loss in peri-implant tissues. Developed by Nobel Biocare, the Xeal™ abutment surface protects the underlying bone, supports stable soft tissue integration, and has been shown to reduce marginal bone loss and promote healthier mucosa compared to machined abutments. However, previous studies have mostly relied on clinical and radiographic evaluations, without three-dimensional evaluation or microbiological analysis. This study aimed to evaluate peri-implant marginal bone loss (MBL), digital evaluation of peri-implant soft tissue, and differences in the microbial composition of the oral microflora colonizing the soft tissue/abutment interface between Multi-unit Abutments Xeal™ and conventional titanium multi-unit abutments placed in the posterior region.

Eligibility

Primary outcome measure(s)

• qPCR analysis outcomes of microbiological samples — 12 month follow-up
  Microbiological composition will be the primary outcome measure, assessed at the T1-T4 time points up to 12 months after prosthesis loading

Trial sites (1)

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