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Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

Not Applicable
Active, not recruiting
Conditions
Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Interventions
Procedure: buccal bone augmentation
Registration Number
NCT03319758
Lead Sponsor
Sun Yat-sen University
Brief Summary

The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

Detailed Description

The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
thin or dehiscences buccal platebuccal bone augmentationImmediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.
Primary Outcome Measures
NameTimeMethod
Radiographic bone volumeUp to 10 years after baseline

Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Secondary Outcome Measures
NameTimeMethod
Visual analogue scale (VAS)Up to 10 years after baseline

A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement

Papilla volumeUp to 10 years after baseline

Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Change of Pink and white esthetic scores (PES/WES)Change from baseline up to 10 years after implantation

Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Buccal marginal recessionUp to 10 years after baseline

Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Oral health impact profile shortened version (OHIP-I)Up to 10 years after baseline

A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Width of keratinized gingivaUp to 10 years after baseline

Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Probing depthUp to 10 years after baseline

Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Modified plaque indexUp to 10 years after baseline

Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Implant survivalUp to 10 years after baseline

Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Modified bleeding indexUp to 10 years after baseline

Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Trial Locations

Locations (1)

Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University

🇨🇳

Guangzhou, Guangdong, China

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