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

NCT ID: NCT05952765

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-06-30

Brief Summary

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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

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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

Conditions

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Prostheses Endosseous Dental Implant Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Immediate implant

Intervention Type PROCEDURE

* Local anesthesia Septanest specialĀ® 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.

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.

Group Type ACTIVE_COMPARATOR

Immediate implant

Intervention Type PROCEDURE

* Local anesthesia Septanest specialĀ® 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.

Interventions

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Immediate implant

* Local anesthesia Septanest specialĀ® 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mihad Ibrahim

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hosny Mostafa, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Oral and Dental Medicine- Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mihad Ibrahim, M.Sc

Role: CONTACT

(+20)1008551124

Facility Contacts

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Manal Hosny Mostafa, Professor

Role: primary

(+202) 23642938

Mohamed Atef Bassiouny, lecturer

Role: backup

(+20)1224302609

Other Identifiers

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7691

Identifier Type: -

Identifier Source: org_study_id

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