Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial

Dental Implants,Peri-implantitis,Smoking Clinical Trial

Official title:

Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766022
• Other study ID #: CTIL-0418-18-RMB
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Rambam Health Care Campus
• Contact: Hadar Zigdon, DMD
• Phone: 9727772983
• Email: h_zigdon[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Aim of this study randomized prospective clinical trial is to examine and compare periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading using the alpha Bio Neo standard diameter implants with conical abutment.

Description:

Peri-implant marginal bone level is one of the most important references criteria to monitor peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding year, is an acceptable criterion to determine implant success.

Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar bone loss and dental implant failure.

Platform switching, also known as platform shifting, is whenever an abutment is used that is smaller in diameter than the implant platform. Platform switching can help prevent crestal bone loss.

The hypothesis of the present study is that the use of conical abutment might reduce marginal bone loss around dental implants in both smokers and non-smokers alike.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age between 20 - 85 years.

2. Written informed consent.

3. In need for a dental implant Adequate alveolar bone Intended to be restored with individual crowns.

4. Heavy smokers (20 Cig/d > 5years) or non / former smokers (> 5 years since cessation).

Exclusion Criteria:

1. Active periodontal disease.

2. Systemic condition and medication that may affect soft and hard tissue.

3. healing Parafunctional occlusal scheme and habits.

4. Pregnancy or intention to become pregnant in the following twelve months.

5. Patient not willing or able to meet the study schedule.

6. Patient in need for simultaneous bone graft or GBR using a membrane barrier.

Related Conditions & MeSH terms

• Dental Implants,Peri-implantitis,Smoking
• Peri-Implantitis

Intervention

Device:
• Neo dental implant Alpha Bio Tec. Ltd.
Neo dental implant is used to restore missing teeth

Locations

Country	Name	City	State
Israel	Rambam Hospital	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implant stability	Osstel measurements	Immediatly after implant installation (day 0) and 4 months after implantation
Primary	marginal bone loss	Standardized periapical radiographs will be used to assess changes in radiographic bone height.	6 months and 18 months after implantation.
Secondary	Implants probing depth (IPD)	will be measured by inserting a probe to the gingival pocket at six sites around implant	4 months, 6 months and 16 months after implantation
Secondary	Bleeding on probing	will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No	4 months, 6 months and 16 months after implantation
Secondary	Labial gingival recession	will be measured using the incisal edge. occlusal plan as a fixed reference point.	4 months, 6 months and 16 months after implantation