Combined Tooth-implant Supported Prostheses

Dental Implant Clinical Trial

— CTISP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712031
• Other study ID #: Orhun ekren
• Status: Completed
• Phase: N/A
• Start date: July 3, 2015
• Est. completion date: September 9, 2022

Study information

• Verified date: January 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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] 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 9, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant

Intervention

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
• 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
• Insertion of 2 Nucleoss T4 dental implants posterior mandible
2 freestanding Nucleoss T4 dental implants is used to support 3 unit fixed partial dentures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ORHUN EKREN

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	At baseline
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	6 months
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	1 year
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	2 years
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	3 years
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	4 years
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	5 years
Primary	Marginal bone loss	Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs	6 years
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	At baseline
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	6 months
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	1 year
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	2 years
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	3 years
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	4 years
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	5 years
Secondary	Modified gingival index	The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3	6 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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