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

July 17, 2023 updated by: Mihad Ibrahim, Cairo University

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.

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 35855
        • Faculty of Oral and Dental Medicine- Cairo University
        • Contact:
        • Contact:
          • Mohamed Atef Bassiouny, lecturer
          • Phone Number: (+20)1224302609
          • Email: Matef@hotmail.com
        • Principal Investigator:
          • Mihad Ibrahim, M.Sc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partially demineralized dentin matrix graft
  • 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.
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.
Active Comparator: xenograft
  • 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink esthetic score
Time Frame: 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.
twelve months after final restoration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical and horizontal radiographic changes in bone dimensions
Time Frame: immediate post operative and twelve months after final restoration
cone beam CT will be used to detect vertical and horizontal changes
immediate post operative and twelve months after final restoration
Midfacial mucosal alteration
Time Frame: 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.
preoperative and twelve months after final restoration
Patient satisfaction
Time Frame: one year after final restoration
a twelve point questionnaire to evaluate patient satisfaction
one year after final restoration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Manal Hosny Mostafa, Professor, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

baseline data and follow up measurements will be shared while keeping patients' identity protected.

IPD Sharing Time Frame

till publication

IPD Sharing Access Criteria

public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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