Immediate Functional Versus Non Functional Implant Loading in the Mandible

Dental Implants Clinical Trial

Official title:

A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521530
• Other study ID #: Dental implants
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 29, 2020

Study information

• Verified date: August 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Description:

Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.

Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.

Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.

The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 29, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Adult patients aged (20-40) years old.

• Missing Posterior tooth or teeth indicated for implant placement.

• Residual alveolar ridge at least 10 mm high and at least 4 mm wide.

Exclusion Criteria:

• Systemic diseases that will contraindicate the surgery.

• Poor Oral Hygiene.

• The patient refuses to undergo the surgery.

• Parafunctional habits.

Related Conditions & MeSH terms

• Dental Implants
• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Other:
• immediate functional implant loading
Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
• immediate non functional implant loading
implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be	immediately Postoperatively
Primary	Change in crestal bone loss	CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss	immediately Postoperatively and after 4 months