AzTrials
AzTrials

Dental ImplantCTISPNCT05712031

Combined Tooth-implant Supported Prostheses

A study testing Insertion of 1 Nucleoss T4 dental implants in posterior mandible, Insertion of 1 Nucleoss T5 dental implants in posterior mandible and Insertion of 2 Nucleoss T4 dental implants posterior mandible in people with Dental Implant and Short Dental Implant, run by ORHUN EKREN.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical study is to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.The main question[s]… Read more about this study

Who is it for?
Ages 37 to 73 yearsHealthy volunteers can take part
Conditions the study is for
Dental Implant, Short Dental Implant
What is being tested?
Insertion of 1 Nucleoss T4 dental implants in posterior mandible, Insertion of 1 Nucleoss T5 dental implants in posterior mandible and Insertion of 2 Nucleoss T4 dental implants posterior mandible
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
No sites listed yet
Study dates
3 Jul 2015to 9 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

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 37 to 73 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with no systemic disorders,
  • Partial edentulous in the posterior mandible unilaterally or bilaterally with maxillary arch fully dentate or have teeth and/or implant supported FPD,
  • At least 3 months of healing after tooth extraction on implant site,
  • Periodontally and endodontically healthy abutment tooth to be combined with implant,
  • Patients who have good oral hygiene habits,
  • Patients smoking less than 10 cigarettes/day,
  • More than 2mm of keratinized gingiva on implant site

Who cannot join

None listed.

About this study

Official title: Clinical Evaluation of Combined Tooth-implant Supported Prosthesis: Controlled Prospective Clinical Study

The goal of this clinical study is to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.The main question[s] it aims to answer are:

1.Is there any difference in terms of mechanical and biological complications as well as marginal bone level between free standing and combined tooth-implant supported 3 unit Fixed Partial Dentures in posterior mandible.

Participants will receive either 2 dental implants(Control group) or 1 standart length dental implants to be combine with abutment tooth or 1 short dental implant to be combine with abutment tooth for supporting 3 unit fixed partial dentures.

Read the detailed description

Purpose: The aim of the study was to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.

Material and methods: 78 partially edentulous patients in the posterior mandible (Kennedy 1 and Kennedy 2), age between 18-65 with no systemic disorders were recruited for the study (n=26). Group 1served as control group and received 2 dental implants for supporting 3 unit fixed partial dentures (FPD). In group 2 dental implants longer than 8 mm and in group 3 shorter than 8 mm were inserted to replace first or second molar combined with first or second premolar respectively to support cement retained 3 units FPD. Periapical radiographs were taken with parallel technique for evaluation of marginal bone resorption (CBL) and modified plaque index (MPI), bleeding index (BI) and sulcus depth of abutment teeth was recorded at the time of FPD insertion, 6 months after FPD insertion and annually. Abutment tooth intrusions, de-cementation of the restoration, porcelain chipping/delamination, framework fracture, abutment screw loosening, abutment and abutment screw fracture, implant fracture were also recorded as complications.

Being tested
Insertion of 1 Nucleoss T4 dental implants in posterior mandible, Insertion of 1 Nucleoss T5 dental implants in posterior mandible, Insertion of 2 Nucleoss T4 dental implants posterior mandible

What participants receive

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

  • Insertion of 1 Nucleoss T4 dental implants in posterior mandibleProcedure or surgery

    Nucleoss T4 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures

  • Insertion of 1 Nucleoss T5 dental implants in posterior mandibleProcedure or surgery

    Nucleoss T5 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures

  • Insertion of 2 Nucleoss T4 dental implants posterior mandibleProcedure or surgery

    2 freestanding Nucleoss T4 dental implants is used to support 3 unit fixed partial dentures

Study groups in NCT05712031
Study groupRoleWhat they receive
Group2ExperimentalMandibular first or second premolar is combined with standard length(8-12mm) dental implants to support 3 unit Fixed Partial Dentures
Receives: Procedure: Insertion of 1 Nucleoss T4 dental implants in posterior mandible
Group3ExperimentalMandibular first or second premolar is combined with short dental implants(5-6mm) to support 3 unit Fixed Partial Dentures
Receives: Procedure: Insertion of 1 Nucleoss T5 dental implants in posterior mandible
Group1Active comparatorStandard length (8-12mm) dental implants are inserted in posterior mandible replacing either first premolar and first molar or second premolar and second molar to support 3 unit fixed partial dentures.
Receives: Procedure: Insertion of 2 Nucleoss T4 dental implants posterior mandible

What is being measured

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

  1. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: At baseline

  2. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 6 months

  3. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 1 year

  4. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 2 years

  5. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 3 years

  6. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 4 years

  7. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 5 years

  8. Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    Measured: 6 years

Secondary outcomes (16)

  1. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: At baseline

  2. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 6 months

  3. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 1 year

  4. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 2 years

  5. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 3 years

  6. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 4 years

  7. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 5 years

  8. Modified gingival index

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

    Measured: 6 years

  9. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: At baseline

  10. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 6 months

  11. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 1 year

  12. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 2 years

  13. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 3 years

  14. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 4 years

  15. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 5 years

  16. Plaque index

    the clinician evaluated plaque accumulation around selected teeth using a periodontal probe and by giving scores to buccal, lingual, mesial and distal surfaces between 0 and 3

    Measured: 6 years

Timeline

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

  1. First posted3 Feb 2023
  2. Study start3 Jul 2015
  3. Primary completion6 Jun 2022
  4. Study completion9 Sep 2022

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
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05712031
Sponsor's protocol ID
Orhun ekren
Acronym
CTISP
Status last verified
Jan 2023
First submitted
14 Jan 2023
Last updated
3 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meffert RM, Langer B, Fritz ME. Dental implants: a review. J Periodontol. 1992 Nov;63(11):859-70. doi: 10.1902/jop.1992.63.11.859.

    PubMed 1453301

  • Rameh S, Menhall A, Younes R. Key factors influencing short implant success. Oral Maxillofac Surg. 2020 Sep;24(3):263-275. doi: 10.1007/s10006-020-00841-y. Epub 2020 Apr 23.

    PubMed 32323043

  • Zarb GA, Lewis DW. Dental implants and decision making. J Dent Educ. 1992 Dec;56(12):863-72.

    PubMed 1487588

  • Al-Omiri MK, Al-Masri M, Alhijawi MM, Lynch E. Combined Implant and Tooth Support: An Up-to-Date Comprehensive Overview. Int J Dent. 2017;2017:6024565. doi: 10.1155/2017/6024565. Epub 2017 Mar 23.

    PubMed 28424733

  • de Paula GA, Silva GC, Vilaca EL, Cornacchia TM, de Magalhaes CS, Moreira AN. Biomechanical Behavior of Tooth-Implant Supported Prostheses With Different Implant Connections: A Nonlinear Finite Element Analysis. Implant Dent. 2018 Jun;27(3):294-302. doi: 10.1097/ID.0000000000000737.

    PubMed 29521677

  • Tsouknidas A, Giannopoulos D, Savvakis S, Michailidis N, Lympoudi E, Fytanidis D, Pissiotis A, Michalakis K. The Influence of Bone Quality on the Biomechanical Behavior of a Tooth-Implant Fixed Partial Denture: A Three-Dimensional Finite Element Analysis. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):e143-e154. doi: 10.11607/jomi.5254.

    PubMed 27861651

  • Hosny M, Duyck J, van Steenberghe D, Naert I. Within-subject comparison between connected and nonconnected tooth-to-implant fixed partial prostheses: up to 14-year follow-up study. Int J Prosthodont. 2000 Jul-Aug;13(4):340-6.

    PubMed 11203652

  • Naert IE, Duyck JA, Hosny MM, Van Steenberghe D. Freestanding and tooth-implant connected prostheses in the treatment of partially edentulous patients. Part I: An up to 15-years clinical evaluation. Clin Oral Implants Res. 2001 Jun;12(3):237-44. doi: 10.1034/j.1600-0501.2001.012003237.x.

    PubMed 11359481

  • Gunne J, Astrand P, Lindh T, Borg K, Olsson M. Tooth-implant and implant supported fixed partial dentures: a 10-year report. Int J Prosthodont. 1999 May-Jun;12(3):216-21.

    PubMed 10635188

  • Nickenig HJ, Schafer C, Spiekermann H. Survival and complication rates of combined tooth-implant-supported fixed partial dentures. Clin Oral Implants Res. 2006 Oct;17(5):506-11. doi: 10.1111/j.1600-0501.2006.01259.x.

    PubMed 16958689

  • Schwartz SR. Short Implants: An Answer to a Challenging Dilemma? Dent Clin North Am. 2020 Apr;64(2):279-290. doi: 10.1016/j.cden.2019.11.001. Epub 2020 Jan 2.

    PubMed 32111268

  • Benlidayi ME, Ucar Y, Tatli U, Ekren O, Evlice B, Kisa HI, Baksi U. Short Implants Versus Standard Implants: Midterm Outcomes of a Clinical Study. Implant Dent. 2018 Feb;27(1):95-100. doi: 10.1097/ID.0000000000000710.

    PubMed 29303816

  • Jung RE, Al-Nawas B, Araujo M, Avila-Ortiz G, Barter S, Brodala N, Chappuis V, Chen B, De Souza A, Almeida RF, Fickl S, Finelle G, Ganeles J, Gholami H, Hammerle C, Jensen S, Jokstad A, Katsuyama H, Kleinheinz J, Kunavisarut C, Mardas N, Monje A, Papaspyridakos P, Payer M, Schiegnitz E, Smeets R, Stefanini M, Ten Bruggenkate C, Vazouras K, Weber HP, Weingart D, Windisch P. Group 1 ITI Consensus Report: The influence of implant length and design and medications on clinical and patient-reported outcomes. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:69-77. doi: 10.1111/clr.13342.

    PubMed 30328189

Questions about this trial

What is this clinical trial studying?

A study testing Insertion of 1 Nucleoss T4 dental implants in posterior mandible, Insertion of 1 Nucleoss T5 dental implants in posterior mandible and Insertion of 2 Nucleoss T4 dental implants posterior mandible in people with Dental Implant and Short Dental Implant, run by ORHUN EKREN.

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 7 inclusion and 0 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: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marginal bone loss (time frame: At baseline). The study lists 8 primary outcomes in all. 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 NCT05712031, which also lists 13 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 3 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.

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