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

Alveolar Socket Preservation Clinical Trial

Official title:

Evaluation of Bone Changes of The Extraction Sockets After Immediate Implant or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone "Randomized Controlled Clinical Trial"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690973
• Other study ID #: perio2018
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Alveolar Socket Preservation

Intervention

Drug:
• Alveolar socket preservation with graft and flap surgery
Alveolar socket preservation with xenogenic bone graft and flap surgery

Device:
• Immediate implant placement with bone using flapless surgery
Immediate implant placement with xenogenic bone graft using flapless surgery
• Immediate implant placement with bone using flap surgery
Immediate implant placement with xenogenic bone graft using flap surgery

Drug:
• Alveolar socket preservation with graft and flapless surgery
Alveolar socket preservation with xenogenic bone graft and flapless surgery

Locations

Country	Name	City	State
Egypt	Amr Mohamed Shaarawi	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Aimetti M, Manavella V, Corano L, Ercoli E, Bignardi C, Romano F. Three-dimensional analysis of bone remodeling following ridge augmentation of compromised extraction sockets in periodontitis patients: A randomized controlled study. Clin Oral Implants Res. 2018 Feb;29(2):202-214. doi: 10.1111/clr.13099. Epub 2017 Nov 17. — View Citation

Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume changes	volumetric bone changes by cone-beam computed tomography	1 year