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NCT Number: NCT06554444

Assessment of Early Healing Period of Dental Implants

This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Implant Biological Width Osseointegration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Over the age of 18
  • Systemically healthy
  • Need for implant treatment in unilaterally edentulous posterior mandible
  • Sufficient interocclusal space for implant and restoration placement
  • At least four months passed since tooth extraction
  • Alveolar bone height adequate for implant placement, with a minimum width of 6 mm, and without risking anatomical structures
  • Plaque and bleeding scores of less than 15% in the entire mouth
  • Presence of opposing teeth in occlusion
  • Written informed consent obtained, including permission for the use of data for research purposes

Exclusion criteria

  • Poor oral hygiene
  • Uncontrolled periodontal disease
  • Pregnancy or lactation at any stage of the study
  • Uncontrolled diabetes
  • Patients with suppressed immune systems
  • History of radiotherapy to the head and neck region
  • Diseases or medications affecting bone metabolism
  • Smoking more than 10 cigarettes per day
  • Bone augmentation performed before or concurrently with the implant
  • Failure to achieve primary stability with the implant

Treatment and study plan

Dental implant surgery

Procedure

Dental implants will be placed in edentulous areas.

Primary outcomes

  1. Linear and volumetric changes in the tissue

    Time frame: Preoperative and postoperative 2nd, 4th, and 16th months

    Linear and volumetric changes in the tissue resulting from the alignment of scan data obtained at four different time points.

Secondary outcomes

  1. Keratinized mucosa width (from the edentulous ridge)

    Time frame: Preoperative and postoperative 2nd month

    Keratinized tissue measured from the mid-buccal of the edentulous area using a periodontal probe.

  2. Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)

    Time frame: Postoperative 4th and 16th months

    Keratinized tissue measured from the gingival margin of the dental implant-supported prosthesis to the mucogingival junction using a periodontal probe.

  3. Mucosal thickness (from the edentulous ridge)

    Time frame: Preoperative and postoperative 2nd month

    Mucosal thickness measured from the midpoint of the edentulous area using a periodontal probe.

  4. Mucosal thickness (from the facial aspect of the edentulous ridge)

    Time frame: Preoperative and postoperative 2nd month

    Mucosal thickness measured at the mid-buccal of the edentulous area, from the midpoint between the mucogingival junction and 2 mm apical to the gingival margin of the adjacent tooth, using a endodontic spreader.

  5. Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)

    Time frame: Postoperative 4th and 16th months

    Mucosal thickness measured 3 mm apical to the gingival margin of the implant-supported prosthesis using a endodontic spreader.

  6. Peri-implant pocket depth

    Time frame: Postoperative 4th and 16th months

    Peri-implant pocket depth measured at six points around the dental implant using a periodontal probe.

  7. Modified plaque index

    Time frame: Postoperative 4th and 16th months

    Modified plaque index measured at four points around the dental implant using a periodontal probe.

  8. Modified bleeding index

    Time frame: Postoperative 4th and 16th months

    Modified bleeding index measured at four points around the dental implant using a periodontal probe.

  9. Marginal bone level

    Time frame: Preoperative and postoperative 2nd, 4th, and 16th months

    Marginal bone level measured on periapical radiographs.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Assessment of Volumetric Changes During the Early Healing Period of Dental Implant Treatment: Clinical, Radiographic, and Digital Evaluation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Jul 24, 2026

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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