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NCT Number: NCT02814149

Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

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Key information

Conditions

Jaw, Edentulous, Partially Acquired Absence of Single Tooth Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years old and able to understand an informed consent
  • Adequate oral hygiene to allow for implant therapy consistent with standards of care.
  • Missing a single tooth in the maxillary anterior region
  • Presence of adjacent natural teeth

Exclusion criteria

  • Poor oral hygiene
  • Severe parafunctional habits, for example, bruxing and clenching
  • Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
  • Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
  • Pregnant or expecting to be pregnant
  • History of drug and alcohol abuse
  • History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
  • Radiotherapy in the head and neck area,
  • On certain medications like bisphosphonates or steroids currently or within the past three months
  • Absence of adjacent teeth
  • Unwillingness to return for the follow-up examination
  • Smokers (more than 20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery

Treatment and study plan

Type 1 implant placement

Procedure

Implant is placed immediately following tooth extraction in one surgical procedure

Other names: Immediate implant placement

Type 3 implant placement

Procedure

Implant is placed in the site which is left to heal for 3 months following tooth extraction

Other names: Delayed implant placement

Primary outcomes

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

    Time frame: Up to 10 years after baseline

    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. Radiographic bone volume

    Time frame: Up to 10 years after baseline

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Baoxin Huang

CONTACT

[email protected]

+8615820219260

Xin Liu

CONTACT

[email protected]

+8615902064014

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Jun 27, 2016
Registry last updated
Nov 1, 2019

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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