Clinical trial NCT06313216: Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate
Official title: Efficacy of Autogenous Tooth Plates for the Treatment of Peri-implant Bone Dehiscence Following Immediate Implantation in Maxillary Esthetic Zone: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implant Complication
Peri-Implantitis
Periodontal Diseases
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with duoteck membrane, while group II was grafted by autogenous demineralized tooth graft, but group III was grafted with autogenous demineralized tooth graft with autogenous demineralized tooth plate Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).
Primary purpose: TREATMENT

Brief summary: The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate.

Detailed description: Patients with missing teeth face the prospect of tooth replacement either through the use of removable prostheses, fixed natural teeth-supported prostheses, or implant-supported prostheses. In many circumstances, implants are the alternative to fixed or removable prosthetic appliances.

One of the various indications of implant therapy is the replacement of periodontally hopeless teeth. The successful use of dental implants for more than 3 decades has been extensively documented for both conventional and immediate implant therapy.

The installation of implants in extraction sockets was advocated as a means to reduce the number of surgical procedures; to preserve the dimensions of the alveolar ridge; to reduce the interval between the removal of the tooth and the insertion of the implant supported restoration and furthermore, it may enhance osseointegration by taking advantage of the natural bone healing process around the implant.

A variety of regenerative techniques using combinations of bone grafts and barrier membranes have been suggested to promote bone regeneration in localized defects at implants placed into extraction sockets (Mayfield 1999). Bone substitutes were used to fill the marginal void between the implant and the bone, and barrier membranes were placed to protect the site during healing.

In the presence of fenestration or dehiscence defects, the potential for spontaneous bone formation at such defects is poor, so it is advised to use augmentation procedures for bone enhancement. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants placed in post-extraction sites, and are more successful with immediate and immediate-delayed placement than with conventional delayed placement.

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.

Eligibility criteria: Inclusion Criteria:

* above the age of 18years
* presence of non-restorable maxillary anterior tooth
* had intact socket walls following tooth extraction
* the gingival biotype was thick.

Exclusion Criteria:

* history of systemic condition
* history of using bisphosphonates or other drugs that might impact bone turnover
* a history of smoking during the previous five years,
* a history of any acute infections at the surgical site,
* teeth having root resorptions

Primary outcomes:
measure: Stability Quotient of dental implant (SQDI)
timeFrame: 12-month.
measure: pink esthetic score (PES)
timeFrame: 12-month.
measure: facial marginal bone level (FMBL)
timeFrame: 12-month.
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: Faculty of Oral and Dental Medicine, Kafrelsheikh University
name: Walid AH Elamrousy, PhD
role: PRINCIPAL_INVESTIGATOR
References: