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Active, not recruitingNCT06165913Updated Dec 12, 2023

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

An interventional study of Early implant placement(type II) and Early implant placement (type III) in Bone Loss and Dental Implants, sponsored by Tanta University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 months after the study started (first participant enrolled May 2023, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Loss
  • Dental Implants

Keywords

  • facial bone loss
  • early implant placement
  • bone changes after implant
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

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

    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)

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

    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

  • ProcedureEarly 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

  • ProcedureEarly 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-12 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

Secondary outcomes

  1. The Plaque index

    The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Plaque index

    Time frame: 6-12 months

  2. The Bleeding on probing

    The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Bleeding on probing.

    Time frame: 6-12 months

  3. 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.

    Time frame: 12 months

07

Study locations

1 site
  • Tanta University faculty of dentistry
    Tanta, 31773, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165913
Lead sponsor
Tanta University
Responsible party
Ahmed Ali Abdelkader Radwan (principle investigator, Tanta University) — Principal investigator
First posted
Dec 12, 2023
Start date
May 30, 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 12, 2023

Study contacts

Rehab F Ghouraba, PHD
study director · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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