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EdentulismNCT07891117

Multi-Evaluation of Dental Abutments With Different Surfaces

A study testing Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC and Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC in people with Edentulism and Dental Implant, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Edentulism, Dental Implant, Prosthetic Abutment
What is being tested?
Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC and Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2026to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)1 site, 1 recruiting
  • Kutahya Health Sciences University Faculty of Dentistry

    Kütahya, 43100

    Berceste Guler Ayyildiz, Assoc. Prof. Dr., 905059359207, berceste.guler@ksbu.edu.tr

    Seyma Eken, Assist. Prof. Dr., 905518489820, seyma.eken@ksbu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Multimodal Evaluation-Clinical, Radiological, Microbiological, and 3D Soft Tissue Analysis-of Dental Abutments With Different Surfaces in the Posterior Region

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.

Read the detailed description

The study will include 44 patients (88 implants) with tooth loss in the maxillary or mandibular posterior region, for whom implant-supported fixed prostheses (supported by two implants each) are planned. These two-unit, splinted, implant-supported bridges will utilize two different types of abutments. Each implant will be randomly assigned to either the control group or the test group using the sealed-envelope method.

All patients will undergo the same surgical procedure and receive the same type of dental implant, in accordance with the established protocol. For the placement of both provisional and definitive fixed prostheses, multi-unit abutments with a "Xeal™" surface will be used for the test group, while titanium multi-unit abutments will be used for the control group.

Prior to surgery, clinical measurements will be recorded, and the peri-implant soft tissues will be digitally scanned using an intraoral scanner (IOS). For both abutment groups, the thickness and width of the keratinized mucosa, as well as the implant placement site, will be measured digitally with the aid of an intraoral scanner (IOS). Before and during the dental implant procedure, the bone thickness around the implant site-in the mesial, distal, buccal, and lingual/palatal directions-and the height of the supracrestal tissue will be recorded.

The dental implants will be placed, and the multi-unit abutments will be tightened to the appropriate torque values. Primary and secondary stability values for the implants will be measured via the multi-unit abutments.

Subsequently, provisional fixed prostheses will be fabricated. After 3 months, the definitive prostheses will be constructed.

For the purpose of radiographic evaluation; Standard periapical radiographs will be taken postoperatively (Tb), immediately after prosthetic loading (T0), and at 1 month (T1), 3 months (T2), 6 months (T3), and 1 year (T4). Marginal bone loss (MBL) will be assessed using measurements taken from these standard periapical radiographs with the aid of software throughout the one-year follow-up period. Following the surgery-at time points T0, T1, T2, T3, and T4-digital soft tissue assessment will be performed using an intraoral scanner (IOS), clinical parameters will be recorded, and subgingival microbial samples will be collected from the deepest pocket area of each implant.

Being tested
Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC, Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC
Keywords
edentulism, posterior region, screw-retained, digital, prosthetic abutment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CCDevice

    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 CCDevice

    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 groups in NCT07891117
Study groupRoleWhat they receive
Control groupExperimentalAccording 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.
Receives: Device: Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC
Test groupExperimentalAccording to the protocol, each patient will receive two Nobel TiUltra™ implant Parallel CCs, with one implant being fitted with a Multi-unit Abutments Xeal™.
Receives: Device: Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 month follow-up

Secondary outcomes (3)
  1. Marginal bone level changes (ΔMBL) (mm)

    Peri-implant ΔMBL (change in marginal bone loss) values during the period from T0 to T4 (from the time of prosthetic loading up to 12 months) post-loading on periapical radiographs.

    Measured: 12 month follow-up

  2. Peri-implant keratinized width changes digitally (mm)

    Differences in keratinized gingival width measurements between time points T0 and T4 (from the time of prosthetic loading up to 12 months), as assessed via IOS, between the two groups

    Measured: 12 month follow-up

  3. Implant stabilization values (ISQ)

    Primary and secondary stabilization values will be measured at intraoperation and follow-up 3rd months (before prosthetic loading)

    Measured: At intraoperatively and before prosthetic loading session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2026
  2. Study start1 Sep 2026
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07891117
Sponsor's protocol ID
KAD001/2026-01
Other IDs
2026-1872
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nobel Biocare. Data on file.

  • 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.

    PubMed 33851765
  • Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

    PubMed 1058834
  • 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.

    PubMed 4500182
  • 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.

    PubMed 3507627
  • 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

  • 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.

    PubMed 29763495
  • 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.

  • 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.

    PubMed 40641458
  • 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.

    PubMed 30809940
  • Yılmaz HG, Yılmaz SK. Effect of Different Abutment Materials on Health of Peri-İmplant Tissues. EÜ Dişhek Fak Derg 2011; 32: 69-75.

  • 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.

    PubMed 18492075
  • 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.

    PubMed 26073346
  • Singh, S., Saifi, D., Singhal, M. K., & Saxena, I. Rational Design and Characterization of Novel Dental Implant and Surfaces: Mucointegration with Enhanced Osseointegration

Questions about this trial

What is this clinical trial studying?

A study testing Multi-unit Abutments Xeal™ with Nobel TiUltra™ implant Parallel CC and Conventional titanium multi-unit abutments with Nobel TiUltra™ implant Parallel CC in people with Edentulism and Dental Implant, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berceste Guler Ayyildiz, Assoc. Prof. Dr. (905059359207, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

qPCR analysis outcomes of microbiological samples (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07891117, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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