Evaluation of Bone Changes After Immediate Implant Placement or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone

Phase 4

Completed

• Conditions: Alveolar Socket Preservation
• Interventions: Device: Immediate implant placement with bone using flapless surgery; Device: Immediate implant placement with bone using flap surgery; Drug: Alveolar socket preservation with graft and flap surgery; Drug: Alveolar socket preservation with graft and flapless surgery

• Registration Number: NCT03690973
• Lead Sponsor: Cairo University

Brief Summary

The amount of hard tissue resorption following tooth extraction involves prosthetically driven implant placement; therefore, the development of ridge preservation techniques that result in less alveolar bone loss is of great interest, Alveolar ridge preservation are indicated to decrease the loss of ridge volume that follows tooth extraction.However, they do not prevent bone resorption because, depending on the technique.The protocol of placing implants immediately upon tooth extraction has been introduced into clinical practice which aims to preserve the socket from resorption, also immediate implant satisfy the patient as it decrease the time for crown insertion in addition to that it has a good survival.There is not adequate research data to clearly demonstrate that flapless socket preservation techniques are superior to techniques that involve raising a flap, but an animal study reported that the detachment of the periosteum from the buccal site of the ridge leads to an increase of the resorption rate, resulting in an increase of the ridge resorption

Detailed Description

Socket preservation procedures have been performed to preserve hard and soft tissue volume, which can be partially lost after tooth removal. These procedures allow for wider and longer implant placement compared with non-augmented sockets and reduce the need for simultaneous augmentation procedures at the time of implant placement.It is expected that immediate implant avoid crestal resorption in the fresh extraction socket in humans also immediate installation at the time of extraction offers potential advantages for both practitioners and patients. It allows a decrease in treatment time and may result in an increase in patient satisfaction.Also it is expected that flapless procedure include maintenance of the buccal keratinized gingival , and prevention of alterations to the gingival contours and migration of the mucogingival junction that are often experienced after raising a flap

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study Start: 2018-09-30
• Study First Posted: 2018-10-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age: Above 18 years.
2. Patients with single non-restorable teeth in anterior or premolar area.
3. Patients with adequate bone volume for the dental implant procedure.
4. Patients with good oral hygiene
5. Patient consent approval and signing.

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Exclusion Criteria

1. Heavy smokers.
2. Systemic disease that contraindicates surgical implant placement
3. Presence of any acute pathosis at the site of surgery.
4. Patients with thin alveolar ridge.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant placement with bone using flapless surgery	Immediate implant placement with bone using flapless surgery	-
Immediate implant placement with bone and flap surgery	Immediate implant placement with bone using flap surgery	-
Alveolar socket preservation with graft and flap surgery	Alveolar socket preservation with graft and flap surgery	-
Alveolar socket preservation with graft and flapless surgery	Alveolar socket preservation with graft and flapless surgery	-

Primary Outcome Measures

Name	Time	Method
Bone volume changes	1 year	volumetric bone changes by cone-beam computed tomography

Trial Locations

Locations (1)

Amr Mohamed Shaarawi; 🇪🇬 Mansoura, Egypt