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

NCT ID: NCT03690973

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2021-03-30

Brief Summary

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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

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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

Conditions

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Alveolar Socket Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

single blinded

Study Groups

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Alveolar socket preservation with graft and flap surgery

Group Type ACTIVE_COMPARATOR

Alveolar socket preservation with graft and flap surgery

Intervention Type DRUG

Alveolar socket preservation with xenogenic bone graft and flap surgery

Immediate implant placement with bone using flapless surgery

Group Type EXPERIMENTAL

Immediate implant placement with bone using flapless surgery

Intervention Type DEVICE

Immediate implant placement with xenogenic bone graft using flapless surgery

Immediate implant placement with bone and flap surgery

Group Type EXPERIMENTAL

Immediate implant placement with bone using flap surgery

Intervention Type DEVICE

Immediate implant placement with xenogenic bone graft using flap surgery

Alveolar socket preservation with graft and flapless surgery

Group Type EXPERIMENTAL

Alveolar socket preservation with graft and flapless surgery

Intervention Type DRUG

Alveolar socket preservation with xenogenic bone graft and flapless surgery

Interventions

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Alveolar socket preservation with graft and flap surgery

Alveolar socket preservation with xenogenic bone graft and flap surgery

Intervention Type DRUG

Immediate implant placement with bone using flapless surgery

Immediate implant placement with xenogenic bone graft using flapless surgery

Intervention Type DEVICE

Immediate implant placement with bone using flap surgery

Immediate implant placement with xenogenic bone graft using flap surgery

Intervention Type DEVICE

Alveolar socket preservation with graft and flapless surgery

Alveolar socket preservation with xenogenic bone graft and flapless surgery

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mohamed Shaarawi

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Zahran, Phd

Role: STUDY_CHAIR

Cairo University

Ahmed Reda, Phd

Role: STUDY_CHAIR

Cairo University

Locations

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Amr Mohamed Shaarawi

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 29148597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27978602 (View on PubMed)

Other Identifiers

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perio2018

Identifier Type: -

Identifier Source: org_study_id

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