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Combined Tooth-implant Supported Prostheses

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05712031
Acronym
CTISP
Enrollment
78
Registered
2023-02-03
Start date
2015-07-03
Completion date
2022-09-09
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Short Dental Implant

Brief 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.

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.

Interventions

PROCEDUREInsertion 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

PROCEDUREInsertion 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

PROCEDUREInsertion of 2 Nucleoss T4 dental implants posterior mandible

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

Sponsors

ORHUN EKREN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
37 Years to 73 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal bone lossAt baselineMesial and distal marginal bone loss around dental implants is measured by periodical radiographs

Secondary

MeasureTime frameDescription
Modified gingival indexAt baselineThe clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3
Plaque indexAt baselinethe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026