Pink Esthetic Score Around Immediate Implants Using PDDM as Jumping Gap Filling Material.

Not Applicable

Not yet recruiting

• Conditions: Endosseous Dental Implant Failure; Prostheses

• Registration Number: NCT05952765
• Lead Sponsor: Cairo University

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

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-08
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Study Start: 2023-08
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pink esthetic score	twelve months after final restoration	a fourteen point scale to evaluate pink esthetics. The pink esthetic score (PES) estimates the esthetic results of soft tissue surrounding the implant with regarding 7 points : mesial, distal papilla, soft tissue margin, soft tissue contour, alveolar process, colour, texture. the score of zero will be lowest and two will be the highest for each of the seven points with zero being the lowest and 14 being the highest.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	one year after final restoration	a twelve point questionnaire to evaluate patient satisfaction
Vertical and horizontal radiographic changes in bone dimensions	immediate post operative and twelve months after final restoration	cone beam CT will be used to detect vertical and horizontal changes
Midfacial mucosal alteration	preoperative and twelve months after final restoration	rubber base impressions taken before the surgical procedure and 12 months after implant restoration. Then, casts were poured with type IV die stone and optically scanned. The obtained models were compared by digital superimposition in a matching software to measure the vertical alterations of the buccal peri-implant soft tissue.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine- Cairo University; 🇪🇬 Cairo, Cairo Governorate, Egypt