Comparison of Narrow and Regular Implants

NCT04572490 | Completed

• 1 other identifier: 2019/07-4
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a retrospective, parallel, two years longitudinal pilot trial. Twenty-eight patients (mean age: 48.34 ± 6.06) aged between 35 and 60 years and 66 TiUnite surfaces (Nobel Biocare Parallel Conical Connection), bone level dental implant were included in the study. The implants were divided into two different groups according to the NPIs and regular platform implants(RPIs). The mean implant lengths, plaque index(PI), gingival index(GI), periodontal pocket depth(PD), gingival recession(GR), keratinized gingival width(KGW) and bleeding on probing(BOP) values were recorded. The Student's t-test used for between-group comparison.

Conditions

Dental Implant Failed; Alveolar Bone Loss; Complication,Postoperative

Keywords

Dental implants Alveolar bone loss

Outcome Measures

Primary Outcomes (1)

• Marginal bone loss

  Peri-implant alveolar bone loss measurements on software program

  change from baseline marginal bone loss at postoperatively 24. month

Secondary Outcomes (1)

• Keratinized gingival width

  change from baseline peri-implant keratinized gingival width at postoperatively 24. month

Study Arms (2)

Narrow platform implant

All measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs.

Diagnostic Test: periapical radiograph

Regular platform implants

All measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs.

Diagnostic Test: periapical radiograph

Interventions

periapical radiograph DIAGNOSTIC_TEST

alveolar bone loss measurement on standardized parallel periapical radiograph

Narrow platform implant; Regular platform implants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All dental implants involved are the Nobel Biocare Parallel CC brand (Nobel Biocare, Gothenburg, Sweden) with a TiUnite surface, and it defined a regular diameter of 4.3 mm and narrow diameter of 3.75 mm. Dental implants divided into two groups according to implant diameter, the NPI group comprised 3.75 mm diameter (NP, Ø= 3.75 mm) implants, and the RPI group comprised 4.3 mm diameter (RP, Ø= 4.3mm) implants (implant lengths: 10 mm-13 mm).

You may qualify if:

• the presence of a dental implant treated with fixed prosthetic restoration placed in the posterior jaw followed for at least one year after functional loading,
• no active periodontal disease,
• no history of penicillin allergy -
• no radiotherapy to the head and neck region
• smoking less than ten cigarettes per day,
• no bone augmentation surgery before or during dental implant surgery,
• aged over 18,
• mesial or distal additional crown restoration was not performed,
• no use of medications that affect bone metabolism and
• not pregnant or lactating.

You may not qualify if:

• the implants placed in the anterior region,
• immediate placing and loading
• augmented before or using a graft membrane with surgery

Sponsors & Collaborators

• T.C. Dumlupınar Üniversitesi: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Postoperative Complications

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Berceste Guler, PhD

  Kütahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 1, 2020
• Study Start: June 27, 2019
• Primary Completion: August 31, 2019
• Study Completion: October 28, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)