the Peri-implant Tissue Changes Around Implants in the Esthetic Zone Using Demineralized Dentin Graft vs Xenograft

NCT ID: NCT06164353

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2024-09-30

Brief Summary

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.

Detailed Description

Dentin tooth can be classified into three groups according to the degree of demineralization undemineralized dentin (UDD), partially demineralized dentin matrix (PDDM) (70% decalcified) and demineralized dentin matrix (DDM). Some authors have shown that UDD is less effective in bone formation whereas other studies have shown that DDM is biocompatible and also osteoinductive, similar to demineralized bone matrix. Valdes concluded in their in vitro study that PDDM with large particle (1000µm) has much more bone regenerative activity in comparison to UDD. This could be explained because demineralization enhances the osteoinduction capacity of tooth material by exposing organic substances within the teeth to the surface, increasing porosity and surface area, and decreasing crystallinity . Nevertheless, some authors have reported successful bone regeneration applying UDD. UDD can be easily obtained from a dentin grinder, after disinfection and cleaning process. PDDM can be only obtained from the tooth after a partial demineralization process of the dentin. In any case, teeth must be free of restorations and caries, and endodontic teeth must be excluded.

However, several animal studies showed that demineralized dentin matrix (DDM) is not only biocompatible but also osteoinductive, similar to demineralized bone matrix. Dentin also contains some growth factors common to a bone, namely, insulin-like growth factor-II, bone morphogenetic protein (BMP), and transforming growth factor-beta. While APDDM has limited osteogenic potential but could be a suitable scaffold for osteoblastic cells. Furthermore, APDDM resists the rapid resorption of graft material. Complete resorption of DDM and remodeling into host bone has been reported to require >6 months. APDDM appears to resorb more slowly because it contains approximately 70% of original dentin matrix mineral. This partial demineralization of dentin matrix may affect the long-term stability of regenerated bone. While DDM may constitute an excellent BMP-2 carrier, APDDM could be a suitable substrate for cell attachment and differentiation. Notably, partial demineralization of dentin exposes collagen fiber, which enables cells to easily attach to substrate; the growth factors released from APDDM might concurrently stimulate osteoblastic differentiation. Furthermore, residual mineral in APDDM could enhance osteoclastic activity, thereby promoting bone remodeling. These factors may have contributed to the rapid and sufficient bone formation for dental implant placement with primary fixation.

To date, no other trial has been published that has used autogenous dentin as a graft material to resolve the periodontal defects on the distal aspect of the second molar derived from LTM extraction with post-operative clinical and CBCT monitoring. This present study was conducted to compare Early implant placement with Simultaneous Contour Augmentation using Partially demineralized dentin graft covered with a collagen membrane versus Early implant placement with Simultaneous Contour Augmentation using bovine xenograft covered with a collagen membrane in terms of esthetic and bone level changes during the first year of functional loading.

Conditions

Implant Site Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bovine xenograft covered with a collagen membrane

The same procedure of implant placement will be performed but xenograft will be used for augmentation.

In both groups, the placed graft will be covered with a collagen membrane. Finally, tension free wound closure will be attained after periosteal releasing incision and suturing using 5/0 proline interrupted sutures.

An immediate postoperative CBCT scan will be done following the surgical procedure.

Group Type: ACTIVE_COMPARATOR

Partially demineralized dentin graft covered with a collagen membrane

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

Partially demineralized dentin graft covered with a collagen membrane

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana Saeed Hassan Alqahtani

Principal Investigator Rana Saeed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rana Sa Al Qahtani, master

Role: PRINCIPAL_INVESTIGATOR

research ethics committee , cairo university

Locations

Rana Saeed Al Qahtani

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

rana Sa Al Qahtani, master

Role: CONTACT

Phone: +201069792005

Email: rana.saeed@dentistry.cu.edu.eg

nesma mo shemis, phd

Role: CONTACT

Phone: +201069792005

Email: rana.saeed@dentistry.cu.edu.eg

Other Identifiers

PER6-32

Identifier Type: -

Identifier Source: org_study_id