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

Not Applicable

Recruiting

• Conditions: Tooth Loss

• Registration Number: NCT06654141
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Study Start: 2025-02-06
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 (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").
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").
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").
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").
Marginal bone level changes	1 year post implant loading	Measured in millimeters using standardized parallel technique intraoral radiographs
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 (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
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
Implant survival rate	1 year post implant loading	Percentage of implants still in the mouth

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China