Multi-Evaluation of Dental Abutments With Different Surfaces

NCT07891117 | Recruiting

• 2 other identifiers: KAD001/2026-012026-1872
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulism; Dental Implant; Prosthetic Abutment

Keywords

edentulism; posterior region; screw-retained; digital; prosthetic abutment

Outcome Measures

Primary Outcomes (1)

• qPCR analysis outcomes of microbiological samples

  Microbiological composition will be the primary outcome measure, assessed at the T1-T4 time points up to 12 months after prosthesis loading

  12 month follow-up

Secondary Outcomes (3)

• Marginal bone level changes (ΔMBL) (mm)

  12 month follow-up

• Peri-implant keratinized width changes digitally (mm)

  12 month follow-up

• Implant stabilization values (ISQ)

  At intraoperatively and before prosthetic loading session

Study Arms (2)

Control group

EXPERIMENTAL

According to the protocol, each patient will receive two Nobel TiUltra™ implant Parallel CCs, with one implant being fitted with a Conventional titanium multi-unit abutment.

Device: Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC

Test group

EXPERIMENTAL

According to the protocol, each patient will receive two Nobel TiUltra™ implant Parallel CCs, with one implant being fitted with a Multi-unit Abutments Xeal™.

Device: Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC

Interventions

Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC DEVICE

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.

Test group

Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC DEVICE

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.

Control group

Eligibility Criteria

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

You may qualify if:

• Age\>18 years old
• Systemically healthy patients
• Presence of edentulous areas in the mandibular or maxillary posterior region
• Presence of natural teeth in the opposing arch
• Periodontal health
• Absence of oral or mucosal disease
• Presence of bone suitable for implant placement with a minimum diameter of 3.75 mm and height of 8 mm
• No need for simultaneous augmentation
• Two-unit splinted implant-supported prosthesis
• Prosthetic superstructure made of metal-supported porcelain-fused material
• A healed maxillary or mandibular molar or premolar site (\>3 months) with sufficient bone available for implant placement without the need for bone grafting
• Not having used any antibiotics in the 6 months immediately preceding the surgery.

You may not qualify if:

• Being outside the specified age range
• Systemic disease
• Patients who have received radiotherapy to the head and neck region
• Severe bruxism or clenching
• Patients who smoke more than 10 cigarettes per day
• Use of drugs that suppress the immune system or impair healing, use of steroids or bisphosphonates
• Patients with alcohol or substance dependence
• Patients who do not comply with treatment
• Pregnancy or breastfeeding
• Patients with intellectual retardation
• Untreated periodontal disease
• Use of any drug or device within the 6 months immediately before surgery
• Patients with conditions that could complicate surgical procedures/need advanced bone augmentation procedures
• Allergy to any component of the implant or abutment
• The need for bone or soft tissue reconstruction at the time of implant placement.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Nobel Biocare: collaborator

Study Sites (1)

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (14)

• Nobel Biocare. Data on file.

  RESULT

• Bozkaya S, Uraz A, Guler B, Kahraman SA, Turhan Bal B. The stability of implants and microbiological effects following photobiomodulation therapy with one-stage placement: A randomized, controlled, single-blinded, and split-mouth clinical study. Clin Implant Dent Relat Res. 2021 Jun;23(3):329-340. doi: 10.1111/cid.12999. Epub 2021 Apr 14.

  PMID: 33851765 RESULT

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 RESULT

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 RESULT

• Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

  PMID: 3507627 RESULT

• Nosswitz M, Teale M, Mathes S, Venturato A, Gasser A. Evaluation of Anodized Surfaces Designed for Improved Soft Tissue Integration, Foundation for Oral Rehabilitation; 2019

  RESULT

• Mussano F, Genova T, Laurenti M, Zicola E, Munaron L, Rivolo P, Mandracci P, Carossa S. Early Response of Fibroblasts and Epithelial Cells to Pink-Shaded Anodized Dental Implant Abutments: An In Vitro Study. Int J Oral Maxillofac Implants. 2018 May/Jun;33(3):571-579. doi: 10.11607/jomi.6479.

  PMID: 29763495 RESULT

• Stević, M., Tatić, Z., Biočanin, V., Đurić, D., & Đukić, I. (2021). History of implantology from the aspect of osseointegration and mucointegration. Timočki medicinski glasnik, 46(1), 29-36.

  RESULT

• Te Lin Y, Li C, Korostoff J, Fiorellini JP, Yang J, Chang YC. Three-dimensional digital quantitative analysis of periodontal and peri-implant phenotype-A narrative review. Periodontol 2000. 2025 Jul 11. doi: 10.1111/prd.12639. Online ahead of print.

  PMID: 40641458 RESULT

• Milleret V, Lienemann PS, Gasser A, Bauer S, Ehrbar M, Wennerberg A. Rational design and in vitro characterization of novel dental implant and abutment surfaces for balancing clinical and biological needs. Clin Implant Dent Relat Res. 2019 Mar;21 Suppl 1:15-24. doi: 10.1111/cid.12736. Epub 2019 Feb 27.

  PMID: 30809940 RESULT

• Yılmaz HG, Yılmaz SK. Effect of Different Abutment Materials on Health of Peri-İmplant Tissues. EÜ Dişhek Fak Derg 2011; 32: 69-75.

  RESULT

• Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res. 2008 Jul;19(7):635-41. doi: 10.1111/j.1600-0501.2008.01543.x. Epub 2008 May 19.

  PMID: 18492075 RESULT

• Linkevicius T, Vaitelis J. The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:139-47. doi: 10.1111/clr.12631. Epub 2015 Jun 13.

  PMID: 26073346 RESULT

• Singh, S., Saifi, D., Singhal, M. K., & Saxena, I. Rational Design and Characterization of Novel Dental Implant and Surfaces: Mucointegration with Enhanced Osseointegration

  RESULT

Study Officials

• Berceste Guler Ayyildiz

  Kutahya Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Berceste Guler Ayyildiz, Assoc. Prof. Dr.

CONTACT

905059359207; berceste.guler@ksbu.edu.tr

Seyma Eken, Assist. Prof. Dr.

CONTACT

905518489820; seyma.eken@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: All patients will undergo identical implant surgery procedures as per the proposed protocol. Temporary and permanent fixed prostheses will be placed using Multi-unit Abutments Xeal™ for the test group and titanium multi-unit abutments for the control group. Test group: Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC. Control group: Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

TU (1)