Combined Tooth-implant Supported Prostheses (CTISP)

ORHUN EKREN

Status: Completed

Conditions: Short Dental Implant; Dental Implant

Treatments: Procedure: Insertion of 2 Nucleoss T4 dental implants posterior mandible; Procedure: Insertion of 1 Nucleoss T5 dental implants in posterior mandible; Procedure: Insertion of 1 Nucleoss T4 dental implants in posterior mandible

Study type: Interventional

Funder types: Other

Identifiers

NCT05712031

Orhun ekren

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 37 to 73 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Group2

Experimental group

Description:

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

Treatment:

Procedure: Insertion of 1 Nucleoss T4 dental implants in posterior mandible

Group3

Experimental group

Description:

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

Treatment:

Procedure: Insertion of 1 Nucleoss T5 dental implants in posterior mandible

Group1

Active Comparator group

Description:

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.

Treatment:

Procedure: Insertion of 2 Nucleoss T4 dental implants posterior mandible