Midfacial Gingival Margin Changes Following Immediate Implants.

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

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-05-30

Brief Summary

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Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

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Detailed Description

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Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).

Conditions

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Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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immediate implant placement with CTG and customized healing abutment.

Group 3 (intervention 2 group): immediate implant placement with customized healing abutment

Group Type EXPERIMENTAL

Connective tissue graft /Bone graft/ Customized HA

Intervention Type PROCEDURE

Soft tissue management and augmentation

immediate implant placement with bone grafts till crest

Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment.

Group Type ACTIVE_COMPARATOR

Connective tissue graft /Bone graft/ Customized HA

Intervention Type PROCEDURE

Soft tissue management and augmentation

immediate implant placement with customized healing abutment

Group 2 (intervention 1 group): Immediate implant placement with CTG and customized healing abutment.

Group Type EXPERIMENTAL

Connective tissue graft /Bone graft/ Customized HA

Intervention Type PROCEDURE

Soft tissue management and augmentation

Interventions

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Connective tissue graft /Bone graft/ Customized HA

Soft tissue management and augmentation

Intervention Type PROCEDURE

Other Intervention Names

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Customized Healing abutment

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.
* Good oral hygiene.
* 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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes