Clinical trial NCT05431998: Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone.
Official title: Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. (Randomized Controlled Clinical Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Estetic Zone
Autogenous Tooth Graft
Autogenous Bone Graft
Immediate Implant
Jumping Gap
Crestal Bone Level
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Marginal bone level
timeFrame: 9 months
Secondary outcomes:
measure: post operative pain
timeFrame: 2 weeks
measure: Implant sucess
timeFrame: 12 months
measure: Pink esthetic score
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ciaro University
state: El Manial
Study officials:
affiliation: Cairo University
name: Karim M Fawzy, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Nesma M Shemais, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Rahma H Ahmed, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed T Taha, BDS
role: PRINCIPAL_INVESTIGATOR
References: