Tooth Loss
Conditions
Keywords
ridge preservation, tooth extraction
Brief summary
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.
Interventions
PROCEDUREAlveolar ridge preservation
Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)
Sponsors
Geistlich Pharma AG
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months | 3 months | Percentage of vital bone |
| Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months | 6 months | Percentage of vital bone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating) | 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 |
| Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating) | 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 |
| Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction | At the time of implant placement (3 or 6 months) | Number of days of total or partially impaired activity |
| Patient reported outcomes (number of days of total or partially impaired activity) following implant placement | 4 months post implant placement | Number of days of total or partially impaired activity |
| Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100) | 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). |
| Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months) | 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. |
| Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100) | 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). |
| Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100) | 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). |
| Implant survival rate | 1 year post implant loading | Percentage of implants still in the mouth |
| Marginal bone level changes | 1 year post implant loading | Measured in millimeters using standardized parallel technique intraoral radiographs |
| Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100) | 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). |
| Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months) | 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. |
Countries
China
Contacts
Primary ContactXinbo Yu, BDS
Outcome results
None listed