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

NCT03690973 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: perio2018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Alveolar Socket Preservation

Keywords

Bone graft; Immediate dental implant; Flap; Flapless

Outcome Measures

Primary Outcomes (1)

• Bone volume changes

  volumetric bone changes by cone-beam computed tomography

  1 year

Study Arms (4)

Alveolar socket preservation with graft and flap surgery

ACTIVE COMPARATOR

Drug: Alveolar socket preservation with graft and flap surgery

Immediate implant placement with bone using flapless surgery

EXPERIMENTAL

Device: Immediate implant placement with bone using flapless surgery

Immediate implant placement with bone and flap surgery

EXPERIMENTAL

Device: Immediate implant placement with bone using flap surgery

Alveolar socket preservation with graft and flapless surgery

EXPERIMENTAL

Drug: Alveolar socket preservation with graft and flapless surgery

Interventions

Alveolar socket preservation with graft and flap surgery DRUG

Alveolar socket preservation with xenogenic bone graft and flap surgery

Alveolar socket preservation with graft and flap surgery

Immediate implant placement with bone using flapless surgery DEVICE

Immediate implant placement with xenogenic bone graft using flapless surgery

Immediate implant placement with bone using flapless surgery

Immediate implant placement with bone using flap surgery DEVICE

Immediate implant placement with xenogenic bone graft using flap surgery

Immediate implant placement with bone and flap surgery

Alveolar socket preservation with graft and flapless surgery DRUG

Alveolar socket preservation with xenogenic bone graft and flapless surgery

Alveolar socket preservation with graft and flapless surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amr Mohamed Shaarawi

Al Mansurah, 35111, Egypt

Location

Related 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.

  PMID: 29148597 BACKGROUND

• 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.

  PMID: 27978602 BACKGROUND

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Amr Zahran, Phd

  Cairo University

  STUDY CHAIR

• Ahmed Reda, Phd

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: September 30, 2018
• Primary Completion: December 30, 2020
• Study Completion: March 30, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)