Combined Tooth-implant Supported Prostheses

Study Overview
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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.

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

Conditions
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Dental Implant, Short Dental Implant

Intervention / Treatment
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* 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


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

Ages Eligible for Study
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Minimum Age: 37 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group2<br>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<br>* Nucleoss T4 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures<br>|
| Experimental: Group3<br>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<br>* Nucleoss T5 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures<br>|
| Active Comparator: Group1<br>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<br>* 2 freestanding Nucleoss T4 dental implants is used to support 3 unit fixed partial dentures<br>|

What is the study measuring?
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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 |