Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets

Implant Site Reaction Clinical Trial

Official title:

Primary Implant Stability of Laser Surface Treated Versus Sand Blasted/Acid Etched Surface Treated Implants in Fresh Extraction Sockets: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04092920
• Other study ID #: PRO 6-3-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: September 2020

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: ahmed mohamed mohamed abd el maksoud, bds
• Phone: 01061597677
• Email: drabdelmaksoud33[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .

Description:

For dental implant to be successful, a direct contact between the bone tissue and the surface of the implant should be developed & this physiological phenomenon is known by the term of osseointegration.

Initially, it was supposed that to achieve osseointegration, implants had to be submerged under the mucosa & left without any loading for a period of 3-4 months in mandible and 6-8 months in maxilla.

Recently immediate implant placement at the time of extraction has become a viable treatment alternative, this approach provides the advantages of decreasing the patient's discomfort, the treatment's duration and costs.

Aiming to reduce healing process to limit such changes in the soft & hard tissues and reducing treatment time, several alterations in both surgical and restorative procedures has been introduced. From an implant design perspective, two approaches including the fields of biomaterials and/or biomechanics have been most utilized; implant body design which aim to increase the primary stability and surface modifications to allow faster osseointegration process.

Rough implant surface is modified by different techniques. Among these different techniques, interest in of using laser to achieve roughened surfaces.

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability & implant placement within the alveoli confines.

Exclusion Criteria:

• • Presence of acute infections in the implant site.

• Presence of fenestrations or dehiscence of the residual bony walls after extraction.

• Heavy smokers more than 20 cigarettes per day.

• Patients with systemic disease that may affect normal healing.

• Psychiatric problems.

• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia.

• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Related Conditions & MeSH terms

• Implant Site Reaction

Intervention

Device:
• laser and SLA
ligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction. atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading . gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of change in implant stability at baseline,2,4,8,12 weeks	measuring implant stability with Resonance Frequency Analysis device using Implant stability quotient (ISQ) units that measure the stiffness and deflection of the implant-bone complex.	3 months