Clinical trial NCT05952765: Pink Esthetic Score Around Immediate Implants Using PDDM as Jumping Gap Filling Material.
Official title: Evaluation of Pink Esthetic Score and Soft Tissue Changes Following Immediate Implants Using Partially Demineralized Dentin Matrix as Jumping Gap Filling Material Versus Xenograft. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostheses
Endosseous Dental Implant Failure
Keywords: alveolar bone
immediate implant
soft tissue changes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft?

Detailed description: This study aims to evaluate the soft tissue changes as well as hard tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix in comparison to xenograft.

Because xenogeneic bone is so readily available in substantial quantities, it has been the subject of notable research. However, because they contain organic material from a foreign species, xenogeneic bones are inherently very antigenic.

According to experimental results, PDDM encourages bone regeneration in a manner like autogenous bone. Both cortical bone and autogenous tooth grafts share similar physical and chemical characteristics, including optimal biodegradability, not requiring a separate surgery to harvest the graft and space maintenance capabilities. PDDM is a valuable comparator to autogenous bone in ARP and around dental implants in guided bone regeneration procedures

Eligibility criteria: Inclusion Criteria:

* Patients above 18 years of age; with non-restorable teeth requiring replacement with immediate implants in the maxillary esthetic zone.
* Absence of active infection at the surgical site.
* Adequate primary stability following immediate implant placement.
* Intact socket walls following the extraction.
* Class I dental socket based on a preoperative CBCT scan
* Buccal plate thickness more than 1 mm and thick biotype.
* Compliant patients who will sign an informed consent and agree to the follow up period.

Exclusion criteria

* Poor oral hygiene or the lack of regular maintenance.
* Individuals with compromised immune system or debilitating systemic disease.
* The presence of parafunctional habits (bruxism or clenching).
* External root resorption.

Primary outcomes:
measure: Pink esthetic score
timeFrame: twelve months after final restoration
Secondary outcomes:
measure: Vertical and horizontal radiographic changes in bone dimensions
timeFrame: immediate post operative and twelve months after final restoration
measure: Midfacial mucosal alteration
timeFrame: preoperative and twelve months after final restoration
measure: Patient satisfaction
timeFrame: one year after final restoration
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine- Cairo University
state: Cairo Governorate
Study officials:
affiliation: Cairo University
name: Manal Hosny Mostafa, Professor
role: PRINCIPAL_INVESTIGATOR
References: