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Clinical Trials/NCT05431998
NCT05431998
Unknown
Not Applicable

Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. (Randomized Controlled Clinical Trial).

Cairo University1 site in 1 country20 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Estetic Zone
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
Marginal bone level
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
August 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Taha Taha Ahmed

Dentist

Cairo University

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-
  • 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

Outcomes

Primary Outcomes

Marginal bone level

Time Frame: 9 months

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.

Secondary Outcomes

  • post operative pain(2 weeks)
  • Pink esthetic score(12 months)
  • Implant sucess(12 months)

Study Sites (1)

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