Marquette University School of Dentistry Graduate Periodontics Clinic
Milwaukee, Wisconsin, 53233, United States
NCT Number: NCT07372183
The goal of this study is to evaluate bone wound healing following extraction and alveolar ridge preservation (bone graft and membrane) clinically, histologically and in relation to gene expression in smokers and non-smokers. Data from a small group of participants will be analyzed after age-matched subjects undergo extraction and alveolar ridge preservation prior to implant placement. The data obtained in this pilot study will be used to plan a full-fledged study involving a larger number of smoking and non-smoking participants to compare the two groups.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Milwaukee, Wisconsin, 53233, United States
All research procedures will start after IRB approval. Patients of the Graduate Periodontics Clinic in need of extraction, bone graft and membrane will be recruited. There will be two groups (smokers and non-smokers) and their demographic and social, periodontal, surgery-related, anatomical and healing variables as well as patient-reported outcomes will be recorded at different time points (immediately before, during and immediately after surgery and 1, 2, 6 weeks and 4 months) in order to evaluate wound healing outcomes and differences between the groups. The demographic and social variables evaluated are age, gender, race, medical history, medications, smoking (via interview and breath test-smokerlyzer) and alcohol consumption (via interview). The periodontal variables are tooth mobility, probing depth, attachment level, gingival and plaque index. The surgery-related variables include intraoperative complications, duration of procedure, anesthetic amount, type and approach and operator experience. The anatomical variables are bone height and width (buccolingual and buccal dimension), bone density (in Cone Beam Computed Tomographies - CBCTs) and gingival width and thickness. The healing variables include wound opening (tested clinically and in photos), bleeding, grafting material discharge, flap necrosis, loose sutures, and temporary restoration adjustment. The patient-reported outcomes are Oral Health Impact Questionnaire-14 (OHIP-14), Visual Analogue Scale (VAS) for pain, swelling and difficulty of mouth opening. At 4 months during the implant placement appointment, a bone core will be harvested via a 3D printed surgical guide based on virtual CBCT planning. The core willl be used of microCT and histological analysis as well as total RNA extraction and RNA sequencing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational study; alveolar ridge preservation
Time frame: Measured before surgery, during surgery and at 4 months
bone width
Time frame: Measured before surgery, during surgery and at 4 months
bone height
Time frame: Bone samples harvested at 4 months
RNA transcriptomic analysis
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: %mineralized bone
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: %osteoid
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: %residual bone graft
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: %soft tissue
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: numbers of osteoblasts and osteoclasts
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: bone mineral density
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: tissue mineral density
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: bone volume / tissue volume (BV/TV)
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular number
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular separation
Time frame: Samples harvested at 4 months
Histological analysis of bone cores: trabecular thickness
Time frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
Oral Health Impact Profile -14 (OHIP-14). Range from 0 (no impact) to 56 (most severe impact).
Time frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
VAS for pain (0-100). Zero indicates no pain and 100 the worst pain imaginable.
Time frame: Measured before surgery and at 1, 2 and 6 weeks, and 4 months
VAS for swelling (0-100). Zero indicates no swelling and 100 the worst swelling imaginable.
Time frame: Measured before surgery, at 1, 2 and 6 weeks, and 4 months
VAS for difficulty of mouth opening (0-100). Zero indicates no difficulty of mouth opening and 100 complete inability to open mouth.
Time frame: Measured at baseline (before surgery)
gingival width
Time frame: Measured at baseline (before surgery)
gingival thickness
Time frame: Measured immediately after surgery, at 1, 2 and 6 weeks and 4 months
wound opening
Time frame: Measured at 1, 2 and 6 weeks and 4 months
bleeding
Time frame: Measured at 1, 2 and 6 weeks and 4 months
grafting material discharge
Time frame: Measured at 1, 2 and 6 weeks and 4 months
flap necrosis
Trial opening soon.
Get NotifiedMarquette University
Other
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