Alveolar Bone Loss, Dehiscence, Tooth Extraction
Conditions
Keywords
Ridge preservation, Collagen membrane, Socket grafting, Buccal bone loss, Delayed implant placement
Brief summary
This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement. Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans. The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.
Detailed description
This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants. Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it. Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement. During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing. The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.
Interventions
PROCEDUREMinimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
DEVICEAlveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
DEVICEResorbable collagen membrane (InterCollagen® Guide)
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.
Sponsors
Debora Dias
SigmaGraft Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding will be applied to the clinical examiner, the radiographic assessor, and the histological analyst, all of whom will remain unaware of group allocation throughout the study. Due to the nature of the surgical procedures, blinding of participants and surgeons is not feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-80 * Indicated for extraction of a single-rooted maxillary tooth * ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions * Presence of both adjacent teeth * No interproximal bone loss * ASA I-II health status * Ability to comply with required procedures, including attending required number of clinic visits
Exclusion criteria
* Patients diagnosed with periodontitis adjacent to the area to be treated * History of allergic reactions to local anesthetics or bone graft material (self-reported); * Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months); * Diagnosis of diabetes mellitus, liver or kidney failure (self-reported); * Presence of active infectious diseases of any kind; * History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported); * Severe hematologic disorders (risk for hemorrhage)(self-reported); * Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs; * Any history of alcohol or drug abuse (self-reported); * Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal dimensional changes (%) | Baseline and 4 months | Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal dimensional changes (%) | Baseline and 4 months | Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change. |
| Vertical dimensional changes (%) | Baseline and 4 months | Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change. |
| Volumetric dimensional changes (%) | Baseline and 4 months | Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change. |
| Mid-buccal soft tissue contour change (mm) | Baseline and 4 months | Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets. Adjacent teeth are used as reference for alignment. A positive value indicates soft tissue gain; a negative value indicates recession. |
| Mid-buccal soft tissue volume change (%) | Baseline and 4 months | Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage. Color-coded deviation maps will illustrate areas of soft tissue collapse or gain. |
| Interproximal papilla height change (mm) | Baseline and 4 months | Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline. A positive value indicates papilla gain; a negative value indicates papilla loss. |
| Wound healing (Wound Healing Index) | 1 week, 2 weeks, 1 month, 4 months | Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention). Lower scores indicate better healing. |
| Incidence of postoperative complications (Percentage) | 1 week, 2 weeks, 1 month, 4 months | Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit. Complications will be recorded by a blinded clinical examiner at each scheduled visit. |
| Postoperative pain | Day 1, Day 3, 1 week | Numeric scale (0-10) for pain after the extraction and ridge preservation procedure. |
| Oral health-related quality of life (OHIP-14) | Baseline, 2 weeks, 4 months | Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire. |
| Feasibility of prosthetically ideal implant placement without additional augmentation | 4 months | Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation. |
| Histological Outcomes | 4 months | In a subset of patients, a bone core biopsy will be obtained. Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement. |
| Patient satisfaction (VAS) | 4 months | Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues |
Countries
United States
Contacts
CONTACTDebora R Dias, DDS, PhD
CONTACTCarla Sanchez, MS
PRINCIPAL_INVESTIGATORDebora R Dias, DDS, PhD
University of Pittsburgh, Department of Periodontics and Preventive Dentistry
Outcome results
None listed