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

NCT05952765 | Unknown DMC

• 1 other identifier: 7691
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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?

Conditions

Prostheses; Endosseous Dental Implant Failure

Keywords

alveolar bone; immediate implant; soft tissue changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vertical and horizontal radiographic changes in bone dimensions

  immediate post operative and twelve months after final restoration

• Midfacial mucosal alteration

  preoperative and twelve months after final restoration

• Patient satisfaction

  one year after final restoration

Study Arms (2)

Partially demineralized dentin matrix graft

EXPERIMENTAL

* 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

xenograft

ACTIVE COMPARATOR

* 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

Interventions

Immediate implant PROCEDURE

* 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.

Partially demineralized dentin matrix graft; xenograft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine- Cairo University

Cairo, Cairo Governorate, 35855, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Manal Hosny Mostafa, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihad Ibrahim, M.Sc

CONTACT

(+20)1008551124; mihad.ibrahim@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PDDM), and which will receive xenograft will be taken according to the randomized numbers placed in opaque sealed envelopes. The number will be picked by the supervisor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: till publication
• Access Criteria: public

Locations

EG (1)