Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence

NCT ID: NCT05891990

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-30

Brief Summary

Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence

Detailed Description

In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Conditions

Immediate Implant

Study Design

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

Study Groups

Intervention group

sticky tooth preparation:

• patient's venous blood will be collected using a 21 g needle with a butterfly handle.
• The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit.
• The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth.

Group Type: EXPERIMENTAL

immediate implant augmented with sticky tooth

Intervention Type: PROCEDURE

• Topical anesthesia will be administered using an infiltration technique.
• Atraumatic extraction will be done with the aid of periotome and Luxators.
• The extraction socket will be debrided to remove any residual debris or granulation tissue.
• Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
• Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
• The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes.
• Finally, the flap will be repositioned and sutured.

Control group

Autogenous demineralized dentin graft preparation

• Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation.
• The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles.
• The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer.
• Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix.
• After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze.

Group Type: ACTIVE_COMPARATOR

immediate implant augmented with autogenous tooth graft

Intervention Type: PROCEDURE

• Topical anesthesia will be administered using an infiltration technique.
• Atraumatic extraction will be done with the aid of periotome and Luxators.
• The extraction socket will be debrided to remove any residual debris or granulation tissue.
• Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
• Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
• The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes.
• Finally, the flap will be repositioned and sutured.

Interventions

immediate implant augmented with sticky tooth

• Topical anesthesia will be administered using an infiltration technique.
• Atraumatic extraction will be done with the aid of periotome and Luxators.
• The extraction socket will be debrided to remove any residual debris or granulation tissue.
• Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
• Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
• The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes.
• Finally, the flap will be repositioned and sutured.

Intervention Type: PROCEDURE

immediate implant augmented with autogenous tooth graft

• Topical anesthesia will be administered using an infiltration technique.
• Atraumatic extraction will be done with the aid of periotome and Luxators.
• The extraction socket will be debrided to remove any residual debris or granulation tissue.
• Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
• Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
• The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes.
• Finally, the flap will be repositioned and sutured.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Non-restorable teeth in the esthetic zone with a defect of labial bone.

• Teeth with no acute inflammation.
• Patients are free from any systemic condition that may affect the healing.
• Availability of bone apical and palatal to the socket to provide primary stability
• Good oral health.
• Willingness to sign the informed consent form.

Exclusion Criteria

• Heavy smoker (> 10 cigarettes/day)
• Pregnant females
• Contraindication for Implant surgery.
• Patients with poor oral hygiene.
• Acute inflammation in the site of implantation and adjacent tissue.
• A history of radiotherapy in the head or neck region.
• Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halla Gamal Mohammed Esmail

OTHER

Sponsor Role: lead

Responsible Party

Halla Gamal Mohammed Esmail

Dentist

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2023

Identifier Type: -

Identifier Source: org_study_id