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NCT Number: NCT05712031

Combined Tooth-implant Supported Prostheses

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.

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Key information

Conditions

Dental Implant Short Dental Implant

Age range

37 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insertion of 1 Nucleoss T4 dental implants in posterior mandible

Procedure

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

Procedure

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

Procedure

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

Primary outcomes

  1. Marginal bone loss

    Time frame: At baseline

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  2. Marginal bone loss

    Time frame: 6 months

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  3. Marginal bone loss

    Time frame: 1 year

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  4. Marginal bone loss

    Time frame: 2 years

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  5. Marginal bone loss

    Time frame: 3 years

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  6. Marginal bone loss

    Time frame: 4 years

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  7. Marginal bone loss

    Time frame: 5 years

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

  8. Marginal bone loss

    Time frame: 6 years

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

Secondary outcomes

  1. Modified gingival index

    Time frame: At baseline

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  2. Modified gingival index

    Time frame: 6 months

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  3. Modified gingival index

    Time frame: 1 year

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  4. Modified gingival index

    Time frame: 2 years

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  5. Modified gingival index

    Time frame: 3 years

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  6. Modified gingival index

    Time frame: 4 years

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  7. Modified gingival index

    Time frame: 5 years

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  8. Modified gingival index

    Time frame: 6 years

    The clinician evaluated bleeding around selected teeth using a periodontal probe and by giving scores between 0 and 3

  9. Plaque index

    Time frame: At baseline

    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

  10. Plaque index

    Time frame: 6 months

    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

  11. Plaque index

    Time frame: 1 year

    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

  12. Plaque index

    Time frame: 2 years

    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

  13. Plaque index

    Time frame: 3 years

    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

  14. Plaque index

    Time frame: 4 years

    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

  15. Plaque index

    Time frame: 5 years

    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

  16. Plaque index

    Time frame: 6 years

    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

Sponsors and collaborators

Lead sponsor

ORHUN EKREN

Other

Registry information

Official study title

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

Acronym: CTISP

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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