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

Not Applicable
Not yet recruiting
Conditions
Endosseous Dental Implant Failure
Prostheses
Interventions
Procedure: Immediate implant
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

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.
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Partially demineralized dentin matrix graftImmediate implant* A high-speed fine finishing stone and saline irrigation will be used to clean extracted teeth from periodontal ligaments, soft tissue attachments, caries, and restorations if present. * Teeth particles will be partially demineralized using nitric acid 2% for fifteen minutes. * Finally, the prepared partially demineralized dentin matrix graft granules will be washed twice with distilled water and phosphate buffered saline * Immediate implant of appropriate dimensions will be placed and the previously prepared partially demineralized dentin matrix graft will be used to graft the jumping gap. * Customized healing abutment will be used. * In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months.
xenograftImmediate implant* After tooth extraction, thorough curettage will be performed. * Immediate implant of appropriate dimensions will be placed, and the jumping gap will be grafted with xenograft "Cerabone" . * Customized healing abutment will be used. * In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months.
Primary Outcome Measures
NameTimeMethod
Pink esthetic scoretwelve 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
NameTimeMethod
Patient satisfactionone year after final restoration

a twelve point questionnaire to evaluate patient satisfaction

Vertical and horizontal radiographic changes in bone dimensionsimmediate post operative and twelve months after final restoration

cone beam CT will be used to detect vertical and horizontal changes

Midfacial mucosal alterationpreoperative 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

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