Combined Tooth-implant Supported Prostheses

NCT ID: NCT05712031

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-03

Study Completion Date

2022-09-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Implant Short Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group2

Mandibular first or second premolar is combined with standard length(8-12mm) dental implants to support 3 unit Fixed Partial Dentures

Group Type EXPERIMENTAL

Insertion of 1 Nucleoss T4 dental implants in posterior mandible

Intervention Type PROCEDURE

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

Group3

Mandibular first or second premolar is combined with short dental implants(5-6mm) to support 3 unit Fixed Partial Dentures

Group Type EXPERIMENTAL

Insertion of 1 Nucleoss T5 dental implants in posterior mandible

Intervention Type PROCEDURE

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

Group1

Standard 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.

Group Type ACTIVE_COMPARATOR

Insertion of 2 Nucleoss T4 dental implants posterior mandible

Intervention Type PROCEDURE

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

Interventions

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Insertion of 1 Nucleoss T4 dental implants in posterior mandible

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

Intervention Type PROCEDURE

Insertion of 1 Nucleoss T5 dental implants in posterior mandible

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

Intervention Type PROCEDURE

Insertion of 2 Nucleoss T4 dental implants posterior mandible

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

37 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ORHUN EKREN

OTHER

Sponsor Role lead

Responsible Party

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ORHUN EKREN

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ORHUN EKREN, PhD

Role: STUDY_DIRECTOR

Cukurova University

References

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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.

Reference Type BACKGROUND
PMID: 1453301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32323043 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1487588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28424733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29521677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27861651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11203652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11359481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10635188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16958689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32111268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29303816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30328189 (View on PubMed)

Other Identifiers

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Orhun ekren

Identifier Type: -

Identifier Source: org_study_id

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