A comparative study on the efficacy of a commercial fibrin adhesive (Tisseel) vis-à-vis silk suture on wound closure following periodontal surgical procedures.

AIMS AND
OBJECTIVES: To evaluate the efficacy of fibrin adhesive sealant (Tisseel(®)), a human biological tissue adhesive, as compared to conventional suture placement in pocket elimination and mucogingival surgical procedures.
MATERIALS AND METHODS: The study sample consisted of 25 patients (10 male and 15 female patients), in the age group of 25-40 years, with localized periodontitis in relation to the anterior region of the maxilla and mandible. They were divided into three surgical groups: Group I, Group II and Group III. Each of these groups was further divided into control and experimental groups. In all the control groups, the flaps/grafts were approximated with 4-0 black braided silk. In the experimental groups, the flaps/grafts were approximated with fibrin adhesive sealant (Tisseel(;)). Clinical parameters were taken pre-operatively.operatively and post-operatively on the 1(st), 2(nd), 3(rd), 7(th), and 10(th), day.
RESULTS: The Fibrin Adhesive System (FAS) showed superior results in all the parameters measured, i.e., hemostasis, fixation of tissues, reduction in plaque and gingival index and probing depth postoperatively.
CONCLUSION: The results of this study indicate that periodontal surgery using FAS enhances various periodontal regenerative surgical procedures.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

The surgical approach in periodontal therapy has become more significant with each passing decade. The restoration of lost periodontal structures has been a topic of interest in the dental profession for years and continues to remain an elusive challenge to those treating periodontal disease.

Goldman and Cohen, in 1980, had stated that healthy gingival sulcus is the touchstone of periodontal therapy, which is the basis of pocket elimination. Surgical periodontal therapy depends on many biological factors in addition to clinical surgical techniques (Ricchetti 1980). The “quid-pro-quo” of periodontal surgery includes asepsis, hemostasis and precise coaptation of the surgical flap which determines an ideal outcome.

Several techniques have been applied to achieve hemostasis and coaptation, such as sutures, adhesive bandages[1] and tissue adhesives. Although sutures have been conventionally used, adhesive agents, cyanoacrylates and adhesive bandages have been used with limited success.

Several studies have demonstrated the usefulness of a fibrin adhesive system (FAS) in many surgical fields[2-5] and the current study was designed to assess the clinical healing characteristics of certain periodontal therapeutic procedures.

The aim of the study was to evaluate the efficacy of fibrin adhesive sealant (Tisseel®), a human biological tissue adhesive, as compared to conventional suture placement in pocket elimination and mucogingival surgical procedures.

MATERIALS AND METHODS

A case control study based on a population selected and scheduled for periodontal surgery was carried out. All subjects in the experimental and control groups were standardized based on the following criteria.

Inclusion criteria

Patients in the age group of 20-45 years, with localized periodontitis in the anterior region of maxilla and mandible, were included in the study.

Exclusion criteria

Patients with systemic diseases such as diabetes mellitus, bleeding disorders, osteoporosis, those undergoing radiation therapy, those who had the habit of smoking and those who had periodontal therapy for the past 6 months were excluded from the study.

The study sample consisted of 25 patients (10 male and 15 female patients) with localized periodontitis in the anterior region of maxilla and mandible. They were randomly selected and divided into three groups (Group I, Group II and Group III). These groups were further divided into control groups where 4-0 black braided silk was used and experimental groups where adhesive sealant (Tisseel;) was used [Figures 1 and 2].

Figure 1

Tisseeling kit

Figure 2

Materials and armamentarium

Study design

Pre-surgical procedure

Selection of patients was followed with oral hygiene instructions, full mouth scaling, root planning. Informed consent was obtained after explaining the proposed nature of the study. Orthopantomograms (OPG) and intraoral periapical radiographs (IOPA) were taken. Casts were fabricated for all the patients. All clinical parameters, i.e., preoperative, operative and postoperative, were taken on 1st , 2nd , 3rd , 7th and 10th days.

The groups were treated as follows.

Group I: Modified Widman flap procedure (Ramfjord and Nissle 1974) was performed. Five patients with localized periodontitis in the right or left side were randomly allocated as control or experimental groups [Figure 3].

Figure 3

Group I

In Group II: Pedicle Graft (Grupe and Warren 1956) was performed for 10 patients with gingival recession in isolated tooth surfaces [Figure 4a–b].

Figure 4

(a and b) Group II

In Group III: Free Gingival Autograft (Bjorn 1963) was performed on 10 patients to increase the width of attached gingiva and the donor site was from the palatal mucosa [Figure 5a–c].

Figure 5

(a-c) Group III

Clinical parameters

Preoperative

Group I - Pocket depth assessment using Williams probe

Operative clinical parameters

Time needed to reconstitute FAS

Time needed to fix tissues

The stability of tissues

Postoperative clinical parameters used

Plaque index

Gingival index on 1st , 2nd , 3rd and 10th postoperative days

Time taken for suture removal

Group I - 7 days

Group II - 10 days

Group III - 10 days

Chair side time

Preparation time

Time taken to fix tissues

Time taken for suture removal

Other clinical parameters

Stability of tissues (score)

0 - Stable at 5 minutes

1 - Unstable at 5 minutes

0 - No bleeding at 1 minute

1 - Bleeding at 1 minutes

5 - Bleeding at 5 minutes

Statistical analysis

Due to the small sample size, no statistically significant test was reported because the two techniques are obviously different and results can be interpreted directly.

RESULTS

The time needed to prepare Tisseel® ranged from 19 to 28 minutes [Table 1]. The time needed to wash, sterilize suture holder, scissors and suture materials ranged from 30 to 35 minutes. Time needed to store instruments or open Tisseel® kit was negligible. Time needed to fix tissues using fibrin glue was about 35 seconds and time needed to suture after various surgical techniques ranged from 3 to 9 minutes [Table 2]. The time needed to remove sutures for various groups ranged from 30 seconds to 3 minutes 50 seconds [Table 3].

Table 1

Time taken to reconstitute Tisseel®

Table 2

Time needed to fix tissue

Table 3

Time needed to remove sutures

Postoperative bleeding

In each case, postoperative bleeding definitely subsided after application of Tisseel® than suturing [Table 4].

Table 4

Postoperative bleeding

Stability of tissues

Tissues were always attached to the underlying layer and were stable within a span of 5 minutes; however, tissues approximated with sutures were unstable and were movable after 5 minutes[6] [Table 5].

Table 5

Stability of tissue positioning

Plaque index

There was a decline in plaque index scores postoperatively in Tisseel® treated cases as compared to sutures [Table 6].

Table 6

Mean value of plaque index – postoperative

Gingival index

There was a relative decline of gingival index scores postoperatively in Tisseel® treated cases than in cases with sutures.

Pocket depth

The postoperative pocket depth was well reduced in the Tisseel® used sites than in the suture sites.

DISCUSSION

A case control study was conducted based on a population selected and scheduled for periodontal surgery. The fixing of the flaps/grafts by fibrin adhesive agent did not require any special skill. The fibrin glue quickly adhered to the tissues, and any excess emitted was easily wiped away. The reconstituted Tisseel® mixture remained stable for the next 4 hours, which allowed the use of the same mix for same or different patients, whereas sutures needed a meticulous technique, thus lengthening the surgical procedure.

Rapid hemostasis was observed soon after application of fibrin glue, making it possible to position grafts or flaps precisely. There was no bleeding after approximation in areas where fibrin glue was applied[7], whereas in those approximated with sutures, there was bleeding after 1 minute. This finding is in accordance with the studies conducted by Pini Prato.[8] Bartolucci[9] stated that a biologic adhesive system that involves physiologic substances appears to augment normal clotting mechanism and therefore has a distinct advantage over suturing and synthetic sealants.

There was a considerable amount of time saved in all the surgical procedures where fibrin adhesive was used. An average of 5-10 minutes was saved by gluing [Table 7]. The results are in agreement with the study conducted by Pini Prato,[10] which showed a time range of 3-19 minutes as the amount of time saved in flap and graft procedures.

Table 7

Average total chair side time

Time taken during surgical procedures using fibrin adhesive is very critical because it

lessens trauma to the patient,

lessens fatigue to the surgeon[11] [Table 7] and

reduces postoperative swelling and operating time was less.

In sutures, it was noticed that there was a marginal fixation of the flap/graft, while fibrin adhesive provided a whole surface of adhesion to the underlying tissues.[12] The mobility of the flap/graft was tested with a blunt instrument after a period of 5 minutes. In fibrin adhesive material (FAM) cases, there was firm adhesion and no mobility of flaps could be elicited.

There was a decline in plaque and gingival index scores in FAM treated cases over a period of 1 week to 10 days.

The postoperative pocket depth was measured using a Williams Periodontal Probe after a period of 1 month. The sulcus depth was reduced in FAM cases when compared to the areas with sutures. This feature is attributed mainly to the firm adhesion of the tissues in FAM cases.[13]

The present study had several limitations. The cost of the material was high; small sample size was involved and a histologic study was not carried out in the FAM group to determine the type of attachment.

CONCLUSION

From the study, we can conclude the following:

FAM has ideal bio-adhesive qualities for fixing of flaps

FAM is easier and quicker to use

FAM lessens the surgical time considerably

FAM provides early hemostasis

Sutures cause inflammation around themselves and also accumulate food and plaque

Pocket depth was reduced

Hence, FAM could be considered as a predictable technique for periodontal regeneration.