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Active, Not Recruiting

NCT Number: NCT03319758

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria were as follows:

  • 18 to 70-year-old;
  • Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
  • Single maxillary anterior teeth (canine to canine);
  • Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4);
  • Presence of adjacent nature tooth;
  • Good compliance;
  • No palatal vertical bone loss;
  • Good oral hygiene.

Exclusion criteria

are as follow:

  • Uncontrolled periodontal or systemic disease;
  • General psychiatric contraindications;
  • More than 20 cigarettes per day;
  • History of head and neck radiotherapy;
  • Pregnant or expecting to be pregnant;
  • Patients with local or generalized healing limitations;
  • Bruxism or other destructive parafunctional habits;
  • Drug abuse or alcohol abuse.

Treatment and study plan

buccal bone augmentation

Procedure

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.

Primary outcomes

  1. Radiographic bone volume

    Time frame: Up 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 outcomes

  1. Change of Pink and white esthetic scores (PES/WES)

    Time frame: 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.

  2. Visual analogue scale (VAS)

    Time frame: 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

  3. Oral health impact profile shortened version (OHIP-I)

    Time frame: 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.

  4. Buccal marginal recession

    Time frame: Up 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.

  5. Papilla volume

    Time frame: Up 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.

  6. Width of keratinized gingiva

    Time frame: Up 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.

  7. Implant survival

    Time frame: Up 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.

  8. Probing depth

    Time frame: Up 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.

  9. Modified plaque index

    Time frame: Up 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.

  10. Modified bleeding index

    Time frame: Up 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Oct 24, 2017
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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