An interventional study of Alveolar ridge preservation in Tooth Loss, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 42 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction
Procedure: Alveolar ridge preservation
Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 6 months after tooth extraction
Procedure: Alveolar ridge preservation
Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
Percentage of vital bone
Time frame: 3 months
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
Percentage of vital bone
Time frame: 6 months
Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (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.
Time frame: 3 months
Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (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.
Time frame: 6 months
Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)
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
Time frame: 2 weeks following tooth extraction and alveolar ridge preservation
Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)
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
Time frame: 2 weeks after dental implant placement
Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction
Number of days of total or partially impaired activity
Time frame: At the time of implant placement (3 or 6 months)
Patient reported outcomes (number of days of total or partially impaired activity) following implant placement
Number of days of total or partially impaired activity
Time frame: 4 months post implant placement
Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Time frame: 2 weeks following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Time frame: 3 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Time frame: 6 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)
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").
Time frame: Up to 30 days post implant crown delivery
Implant survival rate
Percentage of implants still in the mouth
Time frame: 1 year post implant loading
Marginal bone level changes
Measured in millimeters using standardized parallel technique intraoral radiographs
Time frame: 1 year post implant loading
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →