Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone

NCT ID: NCT06592079

Last Updated: 2024-10-15

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-12-31

Brief Summary

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Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

Detailed Description

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This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

Conditions

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Immediate Implants Connective Tissue Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Immediate implant & Connective tissue graft

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Group Type EXPERIMENTAL

Immediate implant and connective tissue graft

Intervention Type PROCEDURE

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Immediate implant with connective tissue graft & bone graft

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will be used to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Group Type ACTIVE_COMPARATOR

Immediate implant with connective tissue graft and bone graft

Intervention Type PROCEDURE

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Interventions

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Immediate implant and connective tissue graft

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Intervention Type PROCEDURE

Immediate implant with connective tissue graft and bone graft

Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient-related criteria:
* Adults at or above the age of 18.
* Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
* The failing tooth will have adjacent and opposing natural teeth.
* Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
* Able to tolerate surgical periodontal procedures.
* Full mouth plaque and bleeding scores less than 20%.
* Compliance with the maintenance program.
* Provide informed consent.
* Accepts the one-year follow-up period.

Teeth related criteria:

* Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
* Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
* Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Exclusion Criteria

* Patients diagnosed with periodontal diseases.
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
* Patients with active infection related at the site of implant/bone graft placement.
* Patients with parafunctional habits
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Norai Ahmed Mohamed Zayed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Norai Ahmed Zayed, Masters Degree

Role: CONTACT

+201221444954

Other Identifiers

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924

Identifier Type: -

Identifier Source: org_study_id

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