Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone.

NCT ID: NCT05431998

Last Updated: 2022-06-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-08-01

Brief Summary

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To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading.

Detailed Description

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Immediate implant placement was introduced in 1978, using a ceramic implant made of Al2O3. Ever since then it has become one of the most successful treatment options to maintain the alveolar bone after tooth extraction, showing success rate of more than 95%. Continuous research and development of immediate implant techniques keep being introduced, stemming from the fact that immediate implant placement is a safe, predictable, and favorable solution after the loss of a tooth.

A 2 mm jumping gap is recommended in the treatment guidelines proposed in an ITI Consensus Conference. This provides sufficient space to fill the bone defect between the exposed implant surface and the facial bone wall with an appropriate bone filler. A gap in these dimensions also provides a space for the formation of a blood clot which can subsequently reorganize into a provisional connective tissue matrix and support the formation of newly formed woven bone. This was demonstrated in a preclinical study in which a wider defect and bone wall dimension were associated with less crestal bone height reduction and more bone to implant contact than a narrower defect and bone wall dimension. Also, immediate placement with a dual-zone augmentation technique, and a socket seal technique utilizing a prefabricated shell made of acrylic and immediate restoration, out of occlusion showed very promising results.

The addition of graft material during immediate implant placement is very common and useful in many cases. Autogenous bone graft is considered to be the gold standard graft material, which makes comparing new graft materials to it sensible. Still, tooth bone graft has been used numerous of times for socket preservation, and it shows good results.

Conditions

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Estetic Zone Autogenous Tooth Graft Autogenous Bone Graft Immediate Implant Jumping Gap Crestal Bone Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The use of demineralized autogenous tooth graft in the jumping gap of the immediate implant

The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high-speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill (Gold Bone Mill, MCT Bio, Korea). Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid (Chemajet Chemicals, Egypt) for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the bone defect around the immediately placed implant.

Group Type EXPERIMENTAL

the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

Intervention Type PROCEDURE

the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

The use of autogenous bone graft in the jumping gap of the immediate implant

A horizontal vestibular incision will be placed below the mucogingival junction and a mucoperiosteal flap will be reflected then autogenous bone particles will be collected from the participants using Automatic Bone Collector Bur (ACM Bur) by NeoBiotch, from the mandibular retro-molar region, speed 300rpm, torque 30Ncm, with irrigation.

Group Type ACTIVE_COMPARATOR

the use of autogenous bone graft in the jumping gap during immediate implant placement

Intervention Type PROCEDURE

the use of autogenous bone graft in the jumping gap during immediate implant placement

Interventions

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the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

Intervention Type PROCEDURE

the use of autogenous bone graft in the jumping gap during immediate implant placement

the use of autogenous bone graft in the jumping gap during immediate implant placement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients in need of extraction of a single, un-restorable tooth in the esthetic zone (Maxillary anteriors and premolars). Only one implant per patient.

An intact buccal plate of bone, or minimally affected. Jumping gap ≥ 2mm . Age 18-60. Medically free patients.

Exclusion Criteria

* Restorable teeth. Teeth with severely damaged or no remaining buccal plate. Acute infection in the implant site. Patients with an insufficient bone to obtain primary stability. Patients in need of sinus bone grafting. A systemic condition that affects bone healing (e.g., diabetes mellitus or bone disease).

Smokers. Poor oral hygiene. Patient with a physical disability that hinders the upkeep of good oral hygiene measures.

Any general contraindication to oral surgery. Participants suffering from diseases that may affect bone or soft tissue healing.

A participant who had radiotherapy or chemotherapy. Psychiatric patient, or with a learning disability, or unable to give consent. Pregnant and nursing women
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Ahmed Taha Taha Ahmed

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karim M Fawzy, PhD

Role: STUDY_CHAIR

Cairo University

Nesma M Shemais, PhD

Role: STUDY_DIRECTOR

Cairo University

Rahma H Ahmed, BDS

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Ahmed T Taha, BDS

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Dentistry Ciaro University

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed T Taha, BDS

Role: CONTACT

00201026776111

Facility Contacts

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Nesma M Shemais, PhD

Role: primary

Other Identifiers

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At1

Identifier Type: -

Identifier Source: org_study_id

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