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

Endosseous Dental Implant Failure Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952765
• Other study ID #: 7691
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Mihad Ibrahim, M.Sc
• Phone: (+20)1008551124
• Email: mihad.ibrahim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endosseous Dental Implant Failure
• Prostheses

Intervention

Procedure:
• Immediate implant
Local anesthesia Septanest special® will be administered prior to the procedure. Teeth extraction will be initiated by intrasulcular incision via 15 C blade without flap elevation. The tooth to be extracted will be luxated atraumatically using periotomes and thin straight elevator and delivered using forceps. The socket will be inspected for integrity, using a UNC graduated periodontal probe. grafting material either experimental or control will be used to graft jumping gap.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine- Cairo University	Cairo	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pink esthetic score	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.	twelve months after final restoration
Secondary	Vertical and horizontal radiographic changes in bone dimensions	cone beam CT will be used to detect vertical and horizontal changes	immediate post operative and twelve months after final restoration
Secondary	Midfacial mucosal alteration	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.	preoperative and twelve months after final restoration
Secondary	Patient satisfaction	a twelve point questionnaire to evaluate patient satisfaction	one year after final restoration