The Evaluation of Facial Bone Changes After Early Implant Placement Protocols "Clinically and Radiographically".

NCT06165913 | Unknown

• 1 other identifier: 1993
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The loss of a single tooth could negatively impact the physiologic occlusion because of the tipping of neighboring teeth and the super-eruption of the opposing teeth. In addition, it compromises the esthetic, especially when anterior teeth are missing, leading to psychological problems such as loss of confidence and avoidance of smiling in public with a defect in phonetics. Restoration of the missing tooth is achieved in many ways, including removable dental appliances, fixed dental prostheses and dental implants. Implant placement is classified into different protocols according to the time of placement in relation to the time of extraction. These different protocols are immediate implant placement (type 1) on the day of extraction; early implant placement (type 2) after 4-8 weeks with soft tissue healing; early implant placement (type 3) after 12-16 weeks with partial bone healing; and delayed dental implant placement (type 4) after complete bone healing at least 6 months after tooth extraction the Aim of the work: to evaluate facial bone changes after early implant placement protocols clinically and radiographically.

Conditions

Bone Loss; Dental Implants

Keywords

facial bone loss; early implant placement; bone changes after implant

Outcome Measures

Primary Outcomes (3)

• The pocket depth will be measured by mm

  the effect of type of implant placement in G1and G2 will be evaluated clinically regarding pocket depth. pocket depth will be measured by mm these measurements will be done after 6 and 12 months post dental implant placement.

  6-12 months

• primary radiographical outcome

  the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss. CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement: A. Vertical facial bone length (VFBL) is the perpendicular distance from implant platform (0) to most coronal point of the facial bone.

  12 months

• primary radiographical outcome

  the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss. CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement: B. Horizontal facial bone thickness (HFBT) is the thickness of facial bone in anterior-posterior direction in respect to implant fixture: Horizontal bone thickness will be measured at margin of platform level 0,1,2and3 mm from implant platform level.

  12 months

Secondary Outcomes (3)

• The Plaque index

  6-12 months

• The Bleeding on probing

  6-12 months

• Horizontal bone thickness will be measured at the middle and apex of implant fixture

  12 months

Study Arms (2)

Group (1): Early implant placement(type II) group.

EXPERIMENTAL

Patients will be scheduled for tooth extraction then performing implant placement between 4-8 weeks later after soft tissue healing.

Procedure: Early implant placement(type II)

Group (2): Early implant placement (type III) group.

EXPERIMENTAL

Patients will be scheduled for tooth extraction and performing implant placement between 12-16 weeks with partial bone healing.

Procedure: Early implant placement (type III)

Interventions

Early implant placement(type II) PROCEDURE

in group 1, Tooth extraction will be performed with care to preserve alveolar bone walls. After 4-8 weeks from tooth extraction, dental implant will be placed

Group (1): Early implant placement(type II) group.

Early implant placement (type III) PROCEDURE

in group 2, Tooth extraction will be performed with care to preserve alveolar bone walls. After 12-16 weeks from tooth extraction, dental implant will be placed.

Group (2): Early implant placement (type III) group.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 20 years old.
• Patients with hopeless tooth in the maxillary anterior premolar region with socket type I indicated for extraction due to failure endodontic treatment, vertical root fracture, …etc.
• Patients in good health with no medical contra-indication that would prevent routine oral surgery.
• Patients with a positive attitude towards oral hygiene

You may not qualify if:

• Patients with relevant medical conditions that may delay healing or compromise implant osseointegration.
• Presence of risk factors as diabetes or smoking.
• Pregnant or lactating women.
• Absence of buccal bone after tooth extraction.
• Insufficient vertical inter-arch space to accommodate the prostheses.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University faculty of dentistry

Tanta, 31773, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rehab F Ghouraba, PHD

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 12, 2023
• Study Start: May 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)