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

NCT05431998 | Unknown

• 1 other identifier: At1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Marginal bone level

  Marginal bone level: The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces (mesial, distal, buccal, and lingual/palatal), measured by CBCT scans.

  9 months

Secondary Outcomes (3)

• post operative pain

  2 weeks

• Implant sucess

  12 months

• Pink esthetic score

  12 months

Study Arms (2)

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

EXPERIMENTAL

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.

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

ACTIVE COMPARATOR

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.

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

Interventions

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

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 of the immediate implant

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Ciaro University

Cairo, El Manial, 4240101, Egypt

Location

Study Officials

• Karim M Fawzy, PhD

  Cairo University

  STUDY CHAIR

• Nesma M Shemais, PhD

  Cairo University

  STUDY DIRECTOR

• Rahma H Ahmed, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed T Taha, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed T Taha, BDS

CONTACT

00201026776111; ahmed-taha@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 1, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

EG (1)