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Immediate Functional Versus Non Functional Implant Loading in the Mandible

Primary Purpose

Dental Implants, Edentulous Alveolar Ridge

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immediate functional implant loading
immediate non functional implant loading
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implants

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

immediate functional loading with temporary crowns

immediate non functional loading with temporary crowns

Arm Description

patients were rehabilitated with immediate functionally loaded implants.

patients were rehabilitated with immediate non-functionally loaded implants.

Outcomes

Primary Outcome Measures

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
Change in crestal bone loss
CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss

Secondary Outcome Measures

Full Information

First Posted
August 18, 2020
Last Updated
August 19, 2020
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04521530
Brief Title
Immediate Functional Versus Non Functional Implant Loading in the Mandible
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implants, Edentulous Alveolar Ridge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immediate functional loading with temporary crowns
Arm Type
Experimental
Arm Description
patients were rehabilitated with immediate functionally loaded implants.
Arm Title
immediate non functional loading with temporary crowns
Arm Type
Experimental
Arm Description
patients were rehabilitated with immediate non-functionally loaded implants.
Intervention Type
Other
Intervention Name(s)
immediate functional implant loading
Intervention Description
Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
Intervention Type
Other
Intervention Name(s)
immediate non functional implant loading
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score
Description
Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be
Time Frame
immediately Postoperatively
Title
Change in crestal bone loss
Description
CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss
Time Frame
immediately Postoperatively and after 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Immediate Functional Versus Non Functional Implant Loading in the Mandible

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