This single-center prospective cohort clinical study was conducted between June 2019 and June 2020 and included participants that were scheduled at Faculty of Dentistry, Arab American University, Palestinian Territory. The study was approved by the Arab American University scientific research council (SRC-17/18 − 10) and performed according to the ethical principles of the Declaration of Helsinki of 1975, as revisited in 2013.
For patients’ selection, the inclusion criteria were any patient requiring at least one single immediate post-extractive implant in the maxilla from right second premolar to left second premolar for a non-mobile tooth, between two natural teeth, with existing contralateral tooth, being at least 20 years old, and able to sign an informed consent form. The exclusion criteria were general contraindications to implant surgery, radiotherapy in the head or neck area, chemotherapy for malignancy in the previous 5 years, uncontrolled diabetes, severe psychiatric disease, patients taking or had taken intravenous bisphosphonates, smoker of more than 9 cigarettes a day, pregnant or lactating women, severe parafunctional activity, acute infection or fistula in the site planned for implant insertion, vertical root fracture including the facial root or horizontal fracture apical to facial bone crest, mobility of grade two or more, moderate or severe periodontitis with more than three millimeters attachment loss, extensive apical lesion, ankylosed tooth, class II or III extraction sockets, and not attending the follow up appointments.
A sum of 40 patients were assessed, of whom 21 were excluded because they did not meet the inclusion criteria (Fig. 1). A total of 19 patients who received 20 implants were included. Selected patients received thorough explanations about the provided treatment and signed a written informed consent in which all treatment risks were explained prior to being enrolled in the study. The 20 implant sites were distributed between the two groups by attempting the socket shield with all the firstly enrolled cases until ten SS were done and any time the buccal shield got mobile, it was removed, and the case was shifted to DZ technique. The remaining cases were done with DZ technique. Therefore, ten implants were placed for each treatment, DZ and SS.
All the surgical and prosthetic procedures were performed by one experienced dentist (R.S.). Patients were followed for at least 8 months after implant placement, and the patients, the outcome assessor (F.M.) who executed the measurements, and the biostatistician were blinded.
Treatment procedures
Scaling and oral hygiene instructions were given for each patient two weeks before the surgery. Cone beam computed tomography (CBCT) was ordered for each patient to evaluate the site for the presence of intact bone plates, if there is any pathology, and to assess the sagittal position of the root. All Patients received a single dose of prophylactic antibiotic 1 hour prior to the intervention (2 g of amoxicillin or 600 mg of clindamycin, if allergic to penicillin). Also, patients rinsed with chlorhexidine mouthwash 0.2% for 1 minute prior to the intervention.
Dual-zone immediate implant placement (DZ)
After the administration of local anesthesia, intrasulcular incision was made around the tooth or retained root to severe the supracrertatal fibers. The tooth was carefully luxated using periotomes and removed with forceps. Then, thorough debridement, curettage, and rinsing with sterile saline were made for the extraction socket, and the socket walls were checked with round ended probe for the presence of any fenestration or dehiscence defects. The case was included in the study if it had intact socket walls or just a small fenestration on the facial wall with intact marginal bone. The osteotomies were then prepared according to the manufacturer’s instructions of the implant system (MegaGen AnyRidge, MegaGen Implant Co., Ltd., South Korea) and the implants were placed with handpiece toward the palatal wall up to 4 mm apical to mid-buccal gingival margin. Periapical radiographs were made to verify the position and angulation of the implants. Insertion torque (IT) and ISQ values (MegaISQ; MegaGen Implant Co., Ltd) were registered for each implant so any implant with IT ≥ 25N/cm and ISQ ≥ 65 was attached with S-shaped customized healing abutment, and any implant with less than these readings was decided for submerged healing. For both situations, granules of FDBA (Mineross, Biohorizons IPH, Birmingham, AZ, USA) were loosely packed into jumping gap regardless of its size and up to gingival margin (dual-zone technique). For implants selected for submerged healing, no primary closure was tried; instead, collagen sponge was placed on top of bone granules and stabilized with 5/0 polyamide nylon horizontal mattress and interrupted sutures (Filapeau, PETERS, France). For provisionalization, a resin-bonded bridge was stabilized to adjacent teeth. Post-surgery, the patients were asked to take antibiotics (amoxicillin 500 mg three times daily for 7 days), chlorhexidine gluconate 0.2% oral rinse 2 times daily for two weeks, and nonsteroidal anti-inflammatory drugs (ibuprofen 400 mg four times daily for 3 days). Patients were also instructed to avoid brushing the area for 2 weeks. Postsurgical evaluation was made at 1, 3, and 6 weeks to verify if there was any complication or infection. Sutures were removed during the 2-week postoperative visits.
Socket-shield immediate implant placement (SS)
After local anesthesia administration, the involved tooth was decoronated up to gingival margin with high-speed diamond chamfer bur. Then, the root canal was widened with successively increasing diameter Gates Glidden burs up to apical region to remove all canal contents verifying the correct length by periapical radiographs. To section the root mesiodistally, a long shank high-speed root resection bur (Komet Dental, Germany) was inserted to the same path created by Gates Glidden until the root was sectioned completely. If possible, the apical portion was aimed to be removed with the palatal portion from the first cut (Fig. 2). A small periotome was used to luxate the palatal section toward the space created by sectioning while maintaining finger support on buccal shield to verify if there is any movement during luxating the palatal segment. If apical portion was not removed with the palatal portion, it was removed by inserting long shank high-speed bur. Thorough debridement, curettage, and rinsing with sterile saline were made to remove any residues of infection. To prepare the coronal portion of the shield, a micro-facial flap was raised to ensure cutting the buccal shield up to bone crest without traumatizing the gingiva, then a bevel was made on the coronal 2 mm portion of the shield internally with high-speed round diamond bur. This bevel was to create more prosthetic space while reducing the risk of shield exposure. A minimum thickness of 1.5 mm and a length of 6 mm were aimed. All procedures were conducted with magnification and high illumination. If there was any fenestration, it was managed by raising a semilunar flap in the apical area gaining access to the defect to ensure complete removal of infected tissue. After assessing the stability of the shield, implant osteotomy was made in the same manner as in DZ with trying to place an implant without touching the shield. Implant diameter (AnyRidge MegaGen, MegaGen Implant Co., Ltd., South Korea) was selected with trying to not contact the shield at the same time be appropriate for the replaced tooth (Fig. 3). The fenestrations when encountered, were grafted using guided bone generation with saline prehydrated FDBA (Mineross, Biohorizons IPH, Birmingham, AZ, USA) and collagen membrane (Mem-Lok RCM, Biohorizons IPH, Birmingham, AZ, USA), then primary closure was achieved with 5/0 polyamide nylon simple interrupted suture (Filapeau, PETERS, France). Granules of FDBA (Mineross, Biohorizons IPH, Birmingham, AZ, USA) were loosely packed into jumping distance regardless of its size and up to gingival margin. All subsequent steps were made the same as with DZ group. The protocol that was followed for performing SS technique in the present study was according to the most recent proposed guidelines [23, 39].
After approximately 4 months, all patients were asked to come to start with the prosthetic part. For non-submerged implants, the customized healing abutment was removed and ISQ was assessed to assess if the implant was ready for definitive prosthesis. If ISQ was ≥ 70, the definitive prosthesis impression was made. Regarding the submerged implants, uncovery was made with punch technique without any soft tissue enhancement, and ISQ was also assessed. All implants were ready for loading. To shape the soft tissue, customized healing abutment was attached to the implant for about four weeks before making the final impression. Pick-up implant-level impression copings were joined to the implants with flowable composite injected into the sulcus to transfer the soft tissue emergence profile to the soft tissue cast, then impression was made with putty soft/light body addition silicone material (Elite HD+, Zhermack SpA, Italy). Subsequently, screw-retained zirconia or metal-ceramic crowns were joined to the implants and the screw was torqued to 35 N/Cm using a calibrated torque wrench (MegaGen Implant Co., Ltd., South Korea). The access holes were sealed with Teflon tape and flowable bulk fill composite (Palfique Bulk Flow, Tokuyama Dental Corporation, Japan). Periapical radiograph was taken immediately after crown delivery as post prosthetic baseline.
Cast analysis
Maintenance and follow-up appointments were scheduled every three months where an impression was made with putty soft/light body addition silicone material (Elite HD+, Zhermack SpA, Italy) at least eight months after implant placement to assess the dimensional ridge changes that occurred post-implantation according to the method described by Tarnow et al. [3]. Measurements were made on type 3 gypsum (Marmodent, Siladent, Germany) casts with electronic digital caliper of 0.01 mm resolution (Salvin Dental Specialties, USA) on both the implant site (test) and the contralateral tooth site (control) at six designated points starting from free gingival margin toward apical area (0, 1, 2, 3, 5 and 7 mm). All measurements were repeated three times at each point by a trained blinded assessor (F.M.), then the means of the distances were recorded for each point (Figs. 4, 5).
Sample size calculation
Sample size was calculated using an online calculator (http://riskcalc.org:3838/samplesize/) [44], considering Type I error rate, α = 0.05, power = 90 % (β = 0.1), ratio of case to control, k = 1, mean (µ) DZ = 0.6, mean (µ) SS = 0.1 based on previous studies [3, 24], and expected population standard deviation, SD = 0.3 [24], the result was 16 for total sample size with 8 for each group. Considering the possibility of drop out, ten for each group was selected.
Statistical analysis
Data were analyzed statistically using the Statistical Package for Social Sciences (SPSS), version 22.0. Means and standard deviation (mean ± SD) were used to describe continuous data, and percentage of cases were used to present categorical data. Data were examined for normality using the Kolmogorov-Smirnov test. For normally distributed data, the differences in means between T and C in the same group or (T-C) between groups were evaluated with Independent Samples t Test, while Mann–Whitney U test was performed for non-normally distributed data. The level of statistical significance was considered at P < .05.