Clinical trial

Clinical and Radiographic Evaluation of the Peri-implant Tissue Changes Around Early Placed Implants in the Esthetic Zone With Contour Augmentation Using Autogenous Partially Demineralized Dentin Graft Versus Xenograft: A RCT

Name

PER6-32

Description

Dentin grafts are categorized into mineralized dentin, partially demineralized dentin matrix (PDDM), and demineralized dentin matrix (DDM). Mineralized dentin can be obtained from a dentin grinder and was found to be less effective in bone formation, while DDM is biocompatible and osteoinductive. Thus, PDDM which requires a partial demineralization process is an interesting point of research to be studied for its ability for contour augmentation in the esthetic zone.

Trial arms

Trial start

2023-06-19

Estimated PCD

2024-06-01

Trial end

2024-09-01

Status

Recruiting

Treatment

Partially demineralized dentin graft covered with a collagen membrane

The stored tooth will undergo grinding using the tooth transformer device. The produced particulate dentin graft will be of a particle size 400-800 µm. Afterwards, these particles will undergo partial demineralization by immersion in in 2% HNO3 for 10 minutes. Then, it will be washed twice using phosphate buffered saline. The exposed implant threads will be covered by partially demineralized autogenous dentin graft in the test group

Arms:

Partially demineralized dentin graft covered with a collagen membrane, bovine xenograft covered with a collagen membrane

Size

Primary endpoint

Peri-implant soft tissue esthetics

After 3 months

Eligibility criteria

Inclusion Criteria: 1. Adults aged ≥20 years. 2. Mild smokers \<1 pack of cigarettes a day 3. Capable of understanding or signing the informed consent form before surgery and capable of meeting oral cleaning requirements for implant placement 4. Healthy individuals with no systemic disease 5. Patients who have a single non-restorable tooth in the esthetic zone 6. Thin buccal plate of bone \< 1mm prior to tooth extraction indicated for early implant placement with the ability to place a bone level implant able to achieve 35 N cm stability after placement. Exclusion Criteria: * 1) A habit of bruxism or inability to achieve requirements for oral cleaning 2) The presence of acute or chronic infection at the site of tooth extraction with lack of treatment for periodontal disease, or x-rays showing loss of alveolar bone on the adjacent teeth 3) Subjects who have a systemic disease which affects bone healing as diabetes and Paget's disease 4) Use of steroid therapy or under current treatment by chemotherapy or radiation therapy to the head and neck (as Bisphosphonates) 5) Pregnant or breastfeeding women

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-12-11

1 organization

1 product

1 indication

Organization

Cairo University

Product

Partially demineralized dentin graft

Indication

Implant Site Reaction