Peri-implant Bone Changes in Post-menopausal Osteoporotic Women

This is a prospective case series study aiming to radiographically assess the changes in alveolar bone width and height after the placement of a SLActive implant (implant with a modified surface that should stimulate bone formation) and 12 months after loading it in post-menopausal osteoporotic women. The null hypothesis is: in post-menopausal osteoporotic women there are no significant changes in the peri-implant alveolar bone after the placement of a SLActive implant and 12 months after loading it in terms of width and height assessed by the use of CBCT images. The aim is to include 20 post-menopausal osteoporotic women with a requirement of a tooth to be replaced. However, considering a potential drop-out rate of 10%, the investigators have planned to increase the recruitment for this trial to 22 postmenopausal women. They will be recruited from the Rheumatology Department and Radiology Department at Barts Health NHS Trust, amongst those patients attending for a consultation with the osteoporosis specialist or for taking a Dual-energy X-ray absorptiometry (DXA) scan. Before starting the visit, post-menopausal women meeting the inclusion criteria will be asked by a study examiner if they agree to be quickly screened for the presence of an intercalate edentulous area (edentulous area in between the teeth)and if they may be interested in taking part into the study. If they agree, a quick dental examination will be performed by a study examiner (a qualified dentist) after the visit. The patients who would qualify for enrolment will receive information on the study, the patient information sheet and consent form, together with a letter to give to their General Dental Practitioner (GDP) in order to be referred to the Centre for Oral Clinical Research. The patients that do not qualify for enrolment will receive a report of the oral screening in case they require dental treatments.

Once the referral letter arrives at the Centre for Oral Clinical Research, Barts Health, the patient will be contacted to answer any further question and to book an appointment to attend the enrolment visit, should they wish.

The study consists of 8 visits that will be performed over a minimum period of 15 months at the Centre for Oral Clinical Research at the School of Dentistry of Queen Mary University of London (QMUL):

1. Enrollment visit:

• Signing of informed consent;
• Recording of any concomitant medication;
• Confirmation of participant eligibility pertaining to the presence of an intercalate single edentulous area fulfilling the inclusion criteria (wisdom teeth and second molars excluded)
• Basic Periodontal Examination (BPE) recording;
• Clinical measurement of the periodontal parameter in the teeth adjacent to the area where the implant will be placed (Probing pocket Depth, PPD; Recession, REC; Plaque Index, PI; Bleeding on Probing, BOP)
• Exit participant if not eligible, arrangement for full-mouth debridement treatment outside the study protocol (if needed) and refer to GDP for other dental problems (such as caries and endodontic infections). If the patient agrees, a letter will be sent to the General Practitioner (GP) to inform about the participation in the study.

1. Full-mouth debridement(within 90 days from enrolment):

• Recording of any Adverse Event (AE) or concomitant medication;
• Oral hygiene instructions and supra and sub gingival debridement of all teeth (as necessary) using ultrasonic and hand instruments as indicated. Local anaesthesia may be used as required to ensure pain control for the participant. In case a participant requires further periodontal treatment, this will be arranged outside the study protocol. No implant will be placed until a condition of periodontal health (no pockets ≥5 mm) will be reached.
• In order to plan the implant placement and according to the clinician's judgment and the complexity of the case, either a Cone Bean Computed Tomography (CBCT) scan or a peri-apical intra-oral x-ray, limited at the area of the implant placement, will be taken.

1. Implant placement (within 120 days from visit 2):

• Recording of any AE or concomitant medication;
• Implant placement. If required, simultaneous horizontal guided regeneration (GBR) of the alveolar bone with a collagen membrane (Collprotect®, Botiss®, Zossen, Germany) and a bovine osteoconductive graft (Cerabone, Botiss®, Zossen, Germany) will be performed;
• Recording of maximum torque at placement;
• Healing cap screwed for semi-submerged healing;
• Resonance frequency analysis;
• Standardized CBCT scan limited to the implant area No sinus lift cases will be taken into consideration.

1. Suture removal (7 days + 3 days from Visit 3):

• Recording of any AE or concomitant medication;
• Clinical evaluation of soft tissue healing (visual inspection of the surgical site and report of any complication);
• Suture removal;
• Resonance frequency analysis;
• Standardized CBCT scan limited to the implant area (if not performed on the day of implant placement).

1. Implant impression (6 weeks ± 7 days from Visit 3):

• Recording of any AE or concomitant medication;
• Implant impression;
• Resonance frequency analysis. In case horizontal GBR is performed simultaneously to implant placement, the implant impression will be performed 11 weeks (+7 days) after implant placement.

1. Implant loading (8 weeks ± 7 days from Visit 3):

• Recording of any AE or concomitant medication;
• Clinical measurement of the periodontal parameter in the teeth adjacent to the implant (PPD, REC, PI, BOP);
• Implant loading and occlusion control;
• Resonance frequency analysis;
• Peri-apical X-ray In case GBR is performed simultaneously to implant placement, the implant impression will be performed 12 weeks (+7 days) after implant placement.

1. 6-months follow-up (6 months ± 14 days from Visit 6):

• Recording of any AE or concomitant medication;
• Clinical measurement of the periodontal parameter in the teeth adjacent to the implant (PPD, REC, PI, BOP) and on the implant
• Polish and oral hygiene instructions;
• Resonance frequency analysis;

1. 12-months follow-up (12 months ± 14 days from Visit 6):

• Recording of any AE or concomitant medication;
• Clinical measurement of the periodontal parameter in the teeth adjacent to the implant (PPD, REC, PI, BOP) and on the implant;
• Polish and oral hygiene instructions;
• Resonance frequency analysis;
• CBCT scan and evaluation of implant survival and success. Photos of the teeth/implant may be taken to facilitate case documentation. The photos will be strictly limited to the implant/teeth area so that subjects will not be identifiable.

At study completion, a letter will be sent to the patient's GDP to inform about the treatments provided and highlight any need for further treatments.