Clinical trial NCT06165913: The Evaluation of Facial Bone Changes After Early Implant Placement Protocols "Clinically and Radiographically".
Official title: The Evaluation of Facial Bone Changes After Early Implant Placement Protocols "Clinically and Radiographically".
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Loss
Dental Implants
Keywords: facial bone loss
early implant placement
bone changes after implant
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The pocket depth will be measured by mm
timeFrame: 6-12 months
measure: primary radiographical outcome
timeFrame: 12 months
measure: primary radiographical outcome
timeFrame: 12 months
Secondary outcomes:
measure: The Plaque index
timeFrame: 6-12 months
measure: The Bleeding on probing
timeFrame: 6-12 months
measure: Horizontal bone thickness will be measured at the middle and apex of implant fixture
timeFrame: 12 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University faculty of dentistry
Study officials:
affiliation: Tanta University
name: Rehab F Ghouraba, PHD
role: STUDY_DIRECTOR
References: