Analysis of patient acceptance following treatment of Miller's class II gingival recession with acellular dermal matrix and connective tissue graft.

OBJECTIVE: Obtaining predictable and aesthetic root coverage has become an important part of periodontal therapy. The search for the appropriate root coverage techniques has resulted in many different approaches. The goal of this study was to evaluate the degree of patient acceptance with acellular dermal matrix (ADM) allograft in the treatment of buccal gingival recession and to compare it with subepithelial connective tissue graft.
MATERIALS AND METHODS: Thirty patients with Miller's class II recessions were treated and randomly assigned to the test group (ADM) and control group (subepithelial connective tissue graft). All patients underwent full periodontal evaluation and pre-surgical preparation, including oral hygiene instructions and scaling and root planing. The exposed roots were thoroughly planed and covered by a graft without any further root treatment. Results were evaluated based on the parameters measuring patient satisfaction and clinical outcome after 6 months of the surgical procedure.
RESULTS: Postoperatively, significant root coverage, reduction in probing depth, gain in clinical attachment level, and increase in widths of keratinized tissue and attached gingiva were observed on intra-group comparison. There was no significant difference in any of the parameters between test and control groups.
CONCLUSION: The subepithelial connective tissue graft and ADM graft were able to successfully treat gingival recession defects; however, the ADM showed better patient acceptance than the connective tissue graft.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Gingival recession is considered to be one of the major manifestations of periodontal disease, which often leads to root sensitivity, root caries, and gingival margin discrepancies compromising patient aesthetics. With the growing emphasis on cosmetic dentistry since 1980s and increasing consciousness about dental aesthetics, patients demand precision treatment for their exposed root surfaces. This generates a need for clinicians to develop materials and techniques that will predictably satisfy these patient-centered aesthetic demands.[1]

Various surgical procedures have been proposed by clinicians to achieve root coverage. These include pedicle graft (laterally repositioned flap, double papilla flap, coronally advanced flap, semilunar flap), autogenous masticatory mucosal graft (free gingival graft), connective tissue (CT) graft, and guided tissue regeneration.[2] Among these procedures, pedicle graft was shown to be predictable by Allen and Miller. However, this technique was recommended in shallow defects only.[3]

In an effort to treat a wide array of defects, subepithelial CT grafts are increasingly used as they achieve high success because of high predictability for root coverage and result in increased width of keratinized tissue. Moreover, it has been shown that CT graft provides excellent color blend and contour as compared to free gingival graft.[4] Although various modifications to the subepithelial CT graft have been developed, they are not without their drawbacks such as second surgical procedure at the palatal site, patient morbidity, more chances of postoperative infection or pain, and limited quantity of donor material.[5] As a result, some patients as well as clinicians feel reluctant to undergo and perform this procedure, respectively.

Therefore, acellular dermal matrix (ADM) graft has been introduced to reduce the number of surgeries, formation of another intraoral surgical site, and also to satisfy patient aesthetic demand of color and tissue blend. ADM allograft is a special skin preparation from human donor, from which the cell components are removed and the ultrastructural integrity of extracellular matrix is maintained. It encourages autogenous epithelial cells’ and fibroblast migration that facilitates its integration into periodontal tissue. ADM has been successfully used as a non-immunogenic graft for burn patients.[67]

The present study was designed to evaluate the patient perception and acceptance of clinical outcomes of ADM allograft in comparison to subepithelial CT graft.

MATERIALS AND METHODS

Study design

The subjects of the study were selected from those attending the outpatient Department of Periodontics. Thirty patients with Miller's class II recessions were included in the study and randomly allocated to ADM group (AlloDerm; Biohorizons, Birmingham, AL, USA) and subepithelial CT group. Inclusion criteria were the presence of 4 mm or more of buccal recession, lack of contradictions for periodontal surgery, commitment to a long-term maintenance program, and the ability to attend recall appointments. Smokers and patients with para-functional habits were excluded from the study. The consent form for the surgical procedure was signed by all patients.

Following selection, all patients received oral hygiene instructions and the initial therapy was performed, which consisted of scaling and root planing.

Clinical parameters

Clinical parameters were recorded immediately prior to surgery and 6 months postoperatively.

Clinical recession (CR): It is the distance from the cemento-enamel junction (CEJ) to the free gingival margin at the mid buccal level.

Probing depth (PD): It is the distance from the free gingival margin to the base of the pocket.

Clinical attachment level (CAL): It is the distance from the CEJ to the base of the pocket.

Width of keratinized gingiva (KT): It is the distance from the most apical position of the gingival margin to the muco-gingival border at the buccal tooth surface.

Width of attached gingiva (AG): It is the difference between the CEJ to the muco-gingival junction and the CEJ to the pocket depth.

All the clinical measurements were made by one examiner only using a periodontal probe (University of North Carolina) preoperatively and 6 months postoperatively.

Patient acceptance was assessed using a three-point rating scale: fully satisfied = 3, satisfied = 2, and unsatisfied = 1. Each patient was questioned about his/her satisfaction with regard to following patient-centered criteria: root coverage, color of gums, shape and contour of gums, surgical procedure (pain during surgery and discomfort), post-surgical phase (pain, swelling, postoperative complication), and cost effectiveness.

Surgical protocol

The surgical procedure was performed under aseptic conditions and local anesthesia for which 2% xylocaine with epinephrine 1:100,000 was given. The surgical procedure was identical in both groups, expect that one group received the subepithelial graft (control group) while the other group received the ADM graft (test group).

An intra-crevicular incision was made through the bottom of the crevice and a partial thickness flap was raised on the buccal aspect of the involved tooth. Two mesial and distal vertical releasing incisions were made including both papillae adjacent to the area of gingival recession. A partial thickness flap was reflected by sharp dissection as close to the periosteum as possible, beyond the muco-gingival junction, and extended until the flap could be passively positioned over the defects without tension. The buccal part of the papilla was de-epithelized to act as a CT recipient site for coronally advanced flap. The exposed root surface was prepared and reduced in convexity by means of curettes and burs to obtain a flattened or concave profile.

The control group was treated with subepithelial CT graft obtained from palate using the Langer and Langer technique. The graft was obtained, positioned on the bed area, and covered with coronally displaced flap with non-absorbable suture (4-0 round: Braided silk; Ethicon, Johnson and Johnson Ltd., India.).

The test group received the ADM graft. The ADM was prepared as per the manufacturer's suggestion. The graft was trimmed to cover the defect and extended 3 mm beyond the osseous defect. The ADM was covered with coronally displaced flap and sutured with non-absorbable suture (4-0 round: Braided silk) without tension.

In Figure 1(a-d), we have shown the treatment of buccal recession on 43 with acellular dermal matrix and in Figure 2(a-c), 6mm of buccal recession on 31 is covered by sub-epithelial connective tissue graft.

Figure 1

(a) Preoperative view showing 4 mm of buccal recession on 43; (b) acellular dermal matrix applied to the site at the level of the CEJ; (c) flap coronally placed over ADM and sutured; (d) postoperative healing after 6 months

Figure 2

(a) Preoperative view showing 6 mm of buccal recession on 31; (b) subepithelial connective tissue graft harvested from palate; (c) postoperative healing at 6 months

Postoperative management and care

Patients were given both verbal and written instructions about postoperative care for the operative site. They were advised to rinse with 0.2% chlorhexidine gluconate solution twice daily and refrain from all mechanical plaque control methods in and around the surgical area for 4-6 weeks.

Prescribed medication included a nonsteroidal anti-inflammatory agent to minimize postoperative pain and swelling and doxycycline hyclate at a dose of 200 mg on the day of surgery and 100 mg per day for the next 7 days. Sutures were removed on the 10th day and professional tooth cleaning was performed to remove plaque and materia alba. Patients were recalled weekly for the first 6 weeks and fortnightly for the next 6 weeks. Neither probing nor subgingival instrumentation was carried out during the first 3 months after surgery. The clinical parameters and postoperative photographs were taken at 6 months postoperatively.

Statistical analysis

The study was conducted to evaluate the patient acceptance of ADM allograft and to compare it with subepithelial CT graft for the treatment of buccal gingival recession. In each group, test (ADM graft) and control (subepithelial CT graft), 15 sites were treated. All the patients who were enrolled in the study reported for scheduled maintenance and postoperative evaluation visits at 6 months. The statistical analysis was performed using the Student's t-test for paired observations. Mean values and standard deviations were calculated for each variable and examination interval. Paired Student's t-test was utilized to evaluate and establish the differences between baseline and post-surgical measurements within a group. Unpaired Student's t-test was utilized to evaluate and establish the differences between two groups (test vs. control) at baseline and 6 months post-surgically.

RESULTS

All patients tolerated the procedures well and reported minimal discomfort. No major complications were encountered. ADM graft used in the study was well tolerated by the gingival tissue and had no adverse effect on the adjacent gingival tissue.

There was a statistically significant reduction in gingival recession and pocket depth, gain in CAL, and increase in widths of KT and AG in the control group and test group after 6 months.

But inter-group comparison showed non-statistical differences in regards to recession depth, PD, CAL, and widths of KT and AG.

DISCUSSION

A variety of surgical procedures have been described to cover gingival recession, such as laterally positioned flap,[8] free gingival graft,[9] subepithelial CT graft,[4] coronally positioned flap,[9] and guided tissue regeneration.[2] But all these procedures provide limited supply of tissue for multiple defects, and increase postoper ative morbidity, discomfort, and the risk of bleeding from palatal site.[1011] To overcome this problem, ADM allograft has been introduced to provide unlimited supply of graft material and to substitute for palatal donor tissue in soft tissue surgeries.

The mean reduction in CR from baseline to 6 months postoperatively for subepithelial CT graft was 2.66 ± 0.90, i.e. 58.7%, and for ADM graft reduction was 2.90 ± 0.88, i.e. 66.9% [Table 1]. There was no statistically significant difference between the results. This is in accordance with the results reported by Aichelmann-Reidy,[7] Rahmani,[12] and Joly et al.[13]

Table 1

Clinical parameters of ADM and subepithelial connective tissue graft at baseline and 6 months postoperatively

There was a mean reduction in PD, as the mean PD at baseline was 1.67 ± 0.48, which decreased to 1.00 ± 0.00 at 6 months postoperatively in the test sites. In the control sites, the baseline was 1.67 ± 0.617, and at 6 months, the measurement was 1.07 ± 0.25 [Table 1]. There was no significant difference between the test and control groups. These results are in accordance with the results of earlier studies.[1114]

CAL demonstrated a mean gain of 3.33 ± 1.32 mm and 3.60 ± 1.05 in the control and test groups, respectively, after 6 months. No significant difference in CAL was present between the test and control groups [Table 1]. This gain is comparable with the findings of Rahmani and Lades.[12]

The subepithelial CT graft demonstrated 1.20 ± 0.94 mm increase in keratinized tissue, whereas ADM graft showed an increase of 1.80 ± 0.67 at 6 months postoperatively, compared to baseline. This difference was statistically nonsignificant. Several studies have reported that a CT graft contributes to the keratinization of the overlying epithelium. However, the mechanism of increase in the width of KT with ADM is unknown. This can be due to the fact that epithelization of CT graft occurs if it is taken from keratinized donor site, and ADM, being taken from keratinized skin, could have the same induction mechanism.[41516] The results of increased keratinized tissue in ADM are in accordance with the results of previous studies.[1013] Harris observed more gain in the width of KT with CT graft than with Alloderm. This might be due to the capacity of the tissue regenerated from periodontal ligament cells.[3]

The mean increase in the width of AG at 6 months from baseline was 2.46 ± 0.91 for ADM and 1.80 ± 0.94 for the control group. But no statistically significant difference was found in the mean values of the width of AG at 6 months between the test and control groups. These findings are in agreement with the findings of Rahmani[12] and Joly et al.[13]

The patients rated the ADM and subepithelial CT graft equally. There was no difference between the patients’ overall satisfaction with either procedure [Tables 2 and 3]. When individual satisfaction criteria were analyzed separately for the two groups, the patients rated the ADM graft better in terms of duration of surgical procedure and postoperative comfort, but high cost of ADM was a major concern as reported by four patients. This was in accordance with the report of Mahajan et al.[17]

Table 2

Total satisfaction score

Table 3

Inter-group comparison of overall patient satisfaction

CONCLUSION

The improvement in all clinical parameters and achievement of acceptable root coverage justifies that ADM graft (Alloderm) can be used as a substitute for subepithelial CT graft.