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NCT Number: NCT06654141

Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets

The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is:

Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets.

Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement.

Participants will:

Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure.

Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material.

Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement.

Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ninth People's Hospital

Shanghai, 201999, China

Location status: Recruiting

Location contact

Xinbo Yu, BDS

CONTACT

[email protected]

86+23271699 ext. 6057

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • ASA (American Society of Anesthesia) status I or II
  • Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV
  • Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021)
  • Radiographic evidence of at least 3 mm of residual bone wall height
  • Presence of at least one adjacent tooth to the extraction site
  • Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis

Exclusion criteria

  • Extraction of multiple adjacent teeth
  • Acute infection associated with the tooth to be extracted or with adjacent teeth
  • Current smokers (>10 cigarettes per day)
  • Uncontrolled diabetes mellitus (HbA1c >7.0)
  • Any active oral or systemic acute infections
  • Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
  • Diseases or medications that may compromise normal wound healing

Treatment and study plan

Alveolar ridge preservation

Procedure

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Primary outcomes

  1. Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months

    Time frame: 3 months

    Percentage of vital bone

  2. Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months

    Time frame: 6 months

    Percentage of vital bone

Secondary outcomes

  1. Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)

    Time frame: 3 months

    Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (3-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

  2. Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)

    Time frame: 6 months

    Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (6-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

  3. Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)

    Time frame: 2 weeks following tooth extraction and alveolar ridge preservation

    Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  4. Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)

    Time frame: 2 weeks after dental implant placement

    Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  5. Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction

    Time frame: At the time of implant placement (3 or 6 months)

    Number of days of total or partially impaired activity

  6. Patient reported outcomes (number of days of total or partially impaired activity) following implant placement

    Time frame: 4 months post implant placement

    Number of days of total or partially impaired activity

  7. Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)

    Time frame: 2 weeks following tooth extraction and alveolar ridge preservation

    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  8. Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)

    Time frame: 3 months following tooth extraction and alveolar ridge preservation

    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  9. Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)

    Time frame: 6 months following tooth extraction and alveolar ridge preservation

    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  10. Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)

    Time frame: Up to 30 days post implant crown delivery

    Patients will be asked to rate their satisfaction in terms of function, comfort and esthetics, using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").

  11. Implant survival rate

    Time frame: 1 year post implant loading

    Percentage of implants still in the mouth

  12. Marginal bone level changes

    Time frame: 1 year post implant loading

    Measured in millimeters using standardized parallel technique intraoral radiographs

Study contacts

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

Xinbo Yu, BDS

CONTACT

[email protected]

86+23271699 ext. 6057

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Collaborators

  • Geistlich Pharma AG

Registry information

Official study title

Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 23, 2024
Registry last updated
Feb 19, 2025

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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