Combined Tooth-implant Supported Prostheses (CTISP)

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Short Dental Implant
• Intervention / Treatment: Procedure: Insertion of 1 Nucleoss T4 dental implants in posterior mandible; Procedure: Insertion of 1 Nucleoss T5 dental implants in posterior mandible; Procedure: Insertion of 2 Nucleoss T4 dental implants posterior mandible

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 73 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group2; Mandibular first or second premolar is combined with standard length(8-12mm) dental implants to support 3 unit Fixed Partial Dentures	Procedure: 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
EXPERIMENTAL: Group3; Mandibular first or second premolar is combined with short dental implants(5-6mm) to support 3 unit Fixed Partial Dentures	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
ACTIVE_COMPARATOR: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	At baseline
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	6 months
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	1 year
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	2 years
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	3 years
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	4 years
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	5 years
Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	At baseline
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	6 months
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	1 year
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	2 years
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	3 years
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	4 years
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	5 years
Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	6 years
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	At baseline
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	6 months
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	1 year
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	2 years
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	3 years
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	4 years
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	5 years
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	6 years

Collaborators and Investigators

• Sponsor: ORHUN EKREN
• Investigators: Study Director: ORHUN EKREN, PhD, Cukurova University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2015
• Primary Completion (ACTUAL): June 6, 2022
• Study Completion (ACTUAL): September 9, 2022

Study Registration Dates

• First Submitted: January 14, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (ACTUAL): February 3, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Orhun ekren

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No