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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06165913
• Other study ID #: 1993
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dental implant is the most reliable option as it replace the natural tooth without affecting the neighboring teeth and preserve the surrounding tooth structure with better functional performance. Implant placement is classified in different protocols according to the time of placement in relation to 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 after 6 months from tooth extraction.

Early Implant placement (type 2) after 4-8 weeks post extraction that allows soft tissue healing, resolution of local pathology, shorter treatment time, increase soft tissue volume makes it easier to manipulate the surgical flaps and enables flap advancement for primary closure.

Early implant placement (type 3) after 12-16 weeks with partial bone healing allow more implant stability than in type 1 and type 2 implant placement. The soft tissues are usually completely recovered, enabling tension free closure of the flap and improves esthetic outcomes. However, bone remodeling is more advanced. Perimplant defects may still be present, but with partial bone healing they are reduced in dimension.

Aim of the Work:

The evaluation of facial bone changes after early implant placement protocols clinically and radiographically.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients above 20 years old.

2. 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.

3. Patients in good health with no medical contra-indication that would prevent routine oral surgery.

4. Patients with a positive attitude towards oral hygiene

Exclusion Criteria:

1. Patients with relevant medical conditions that may delay healing or compromise implant osseointegration.

2. Presence of risk factors as diabetes or smoking.

3. Pregnant or lactating women.

4. Absence of buccal bone after tooth extraction.

5. Insufficient vertical inter-arch space to accommodate the prostheses.

Related Conditions & MeSH terms

• Bone Loss
• Dental Implants

Intervention

Procedure:
• Early implant placement(type II)
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
• Early implant placement (type III)
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.

Locations

Country	Name	City	State
Egypt	Tanta University faculty of dentistry	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	The Plaque index	The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Plaque index	6-12 months
Secondary	The Bleeding on probing	The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Bleeding on probing.	6-12 months
Secondary	Horizontal bone thickness will be measured at the middle and apex of implant fixture	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: • Horizontal bone thickness will be measured at the middle and apex of implant fixture.	12 months