This longitudinal prospective interventional clinical study was conducted on 20 (8 male and 12 female) healthy subjects within the age range of 18–50 years, with hopeless teeth indicated for extraction (Fig. 1a, b).
Inclusion criteria for selection in the present study considered the following conditions which were indicated for extraction like
The study protocol was commenced after obtaining approval from the institutional review board according to the principles of the World Medical Health Association Declaration of Helsinki 2000 for medical research in human subjects. A detailed medical and dental history with required laboratory blood investigations was done. It was made sure that all the patients included in the study belonged to ASA class I physical status. Orthopantamographs (OPG) and intraoral periapical radiographs of the area of interest were taken. Diagnostic casts were made, and customized acrylic stents were fabricated for standardized measurement of soft tissue parameters and marginal bone height levels at the baseline and postoperatively. Clinical parameters like the following were measured at the baseline pre-operatively and 6 months postoperative:
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Gingival index (Loe and Sillness) [8],
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Plaque index (Sillness and Loe) [9],
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Marginal bone levels at four sites (mid-buccal, mid-palatal, mid-mesial, and mid-distal) using the stent [9], (Fig. 2e–h)
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The bucco-palatal/bucco-lingual width of the socket [10],
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Keratinized mucosa index (Cox and Zarb) [11],
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Papillary height measurement using stent [12]. (Fig. 2a–d)
Oral prophylaxis was done 4 weeks before the extraction, and instructions were given on oral hygiene maintenance and its significance on the treatment prognosis. Patients were given one capsule of Augmentin 625 mg 12 h before and the same dose was given along with Ketorolac 10 mg 1 h before the procedure. One tablet of Alprazolam one night before was considered for apprehensive patients.
Surgical procedure
On the day of extraction, firstly, PRF was prepared using Choukron’s protocol. Two percent Xylocaine HCl with adrenaline 1:80,000, crevicular, or sulcular incisions were placed around the indicated tooth with No: 15C Bard-Parker blade. Periotome followed by the Benex system was used for extraction (Fig. 1c, d). The extraction socket was thoroughly irrigated and curetted, followed by an exploration of the extraction socket using UNC-15 probe for fenestration or dehiscence on the buccal plate, if any. Socket grafting was then done using calcium phosphosilicate (Novabone® putty) graft, which was directly delivered to the extraction socket with the cartridge (Fig. 1e). The graft material was packed in 3–4 bulk amounts until the extraction sockets were completely filled to the height of the alveolar crest followed by PRF placement over the graft (Fig. 1f). Then, a resorbable collagen plug (ACE Surgical Supply Co., Inc.) was placed over the PRF, and mattress sutures (5–0 polyamide, Trulon, Sutures India, India) were given which were removed after 1 week. The following post-surgical instructions and medication were given:
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Cap. Augmentin 625 mg was given twice and Tab. Ketorol thrice daily for 5 days.
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Rinse mouth gently using an oral rinse (Chlorhexidine gluconate) twice daily for 15 days.
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Patients were prohibited from chewing or putting any kind of load in the surgical area.
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The patient was asked to apply an ice pack over the operated area intermittently for the first 12 h after the surgery.
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In case prolonged bleeding persisted, patients were asked to report to the hospital.
There was no evidence of any complication during the course of study. The clinical parameters, recorded at the baseline, were re-recorded for the full mouth as well as for the selected sites, at 6 months after extraction using the same stent to standardize the measurements and minimize the error. Only 16 patients (6 males, 10 females) returned for the follow-up examinations at 6 months. The plaque index and gingival index were taken for the full mouth, while keratinized mucosa index, soft tissue height, and marginal bone levels were recorded at the study site at baseline and 6-month intervals.
A bone core was harvested from the center of the socket using a trephine bur during implant placement. Further evaluation of the grafted socket was done by studying the implant stability using the Osstell ISQ system and marginal bone around the implant. Stability was measured at the implant placement and 4 months later, during loading [13]. The alveolar crestal bone levels of the implants were measured during the loading and 1-year post-loading using intraoral periapical radiographs. All the radiographs were taken by a single operator using the long-cone technique to minimize the inter-operator variability in the radiographic measurements.
Outcome measures
The primary outcome measures of this interventional prospective clinical study are to study the:
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Soft tissue profile in grafted sites baseline and 6 months after socket grafting
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Marginal crestal bone changes in grafted sites clinically 6 months post-grafting
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Patterns of bone regeneration in the grafted sites histologically after 6 months of socket grafting
Histomorphometric analysis
Harvested cores were dehydrated with a graded series of alcohols for 9 days. Following dehydration, the specimens were infiltrated with a light-curing embedding resin (Technovit 7200 VLC, Heraeus Kulzer, Wehrheim, Germany) and were then ground into thin longitudinal sections in apicocoronal direction. The ground sections were stained with Stevenel Blue and Von Gieson fuchsin stain and observed under polarized light microscope at low (× 10), medium (× 20), high (× 40), and very high magnifications (× 100).
The secondary outcome measures are:
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Stability of implants placed in the grafted socket using resonance frequency analysis during the placement of the implant and 4 months postoperatively
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Changes in the crestal bone height during the implant placement, loading (4 months postoperatively), and 1-year post-loading