Effectiveness of tissue glue and silk sutures after periodontal flap surgery: A split-mouth clinical study

RESEARCHQUESTION**-**

Whichone amongst the tissue glue and silk suture will have a better periodontalhealth outcome in periodontitis patients?

RESEARCHHYPOTHESIS-

Directionalhypothesis- Tissueglue will be better than silk sutures in terms of periodontalhealth outcomes in periodontitis patients.

Non-Directionalhypothesis- There will be nodifference in tissue glue and silk sutures in terms periodontal health outcomes in periodontitispatients.

AIM OF THE STUDY:

The aim of thisstudy is to compare the effectiveness of flap closure with silk sutures andtissue glue (bioadhesive material).

OBJECTIVES OF THE STUDY:

To determine theeffectiveness of tissue glue with braided silk sutures after a periodontal flapsurgery on the basis of parameters-

Ø  Indices (plaque index, gingival index, healingindex)

Ø  PPD (Probing Pocket Depth)

Ø  CAL (Clinical Attachment Level)

Ø  Post-operative pain and bleeding experiencedby the patient through a questionnaire.

Ø  Time required for completion of suturingduring periodontal flap surgery.

Ø  Assessment of effect of flap closure in silksutures and tissue glue for demographic variables – age and gender.

MATERIALS AND METHODS:

This study will be conducted in the Departmentof Periodontology, Rural Dental Hospital, Loni. Patients between the age range of 31-60 years amongst both thegenders and having periodontitis. The flap closure will be executed with eithersilk sutures or tissue glue to determine the effectiveness of each among thetwo groups.

STUDY DESIGN:

Study Type                  :  Experimental.

StudyDesign               :  Phase IV RandomizedClinical Trial

Periodof Study            :  2 years

StudyStart Date           :  May 2022 (after the IEC approval)

Setting                          :  Department of Periodontology, Rural DentalHospital, Loni.

The subjects will be randomly assigned to two treatmentgroups for deciding the effectiveness of silk sutures and tissue glue afterperiodontal flap surgery.

INCLUSIONCRITERIA

1. Adults aged between 31 to 60 years.

**2.**Patientswith probing depth ≥5mm.

**3.**Patient ready to give informedconsent.

**4.**Patientsof both genders.

**5.**Patientsready to come for follow-ups.

EXCLUSIONCRITERIA

1.    Any systemic illness known toaffect the outcome of periodontal therapy.

2.    Allergic reactions to tissue glue.

3.    Pregnant and lactating women.

4.    Use of tobacco / smoking in anyform.

5.    Patients under anticoagulationtreatment or bleeding disorder.

6.    Patients who hadundergone periodontal treatment within a period of 1 year.

 METHODOLOGY:

All patientssatisfying the above inclusion and exclusion criteria will be given a uniquecode and subjected to a well-defined random allocation method.

Randomization technique**:**Each eligible patient indicated to undergoperiodontal flap surgery will be subjected to random lottery method.

Each patient willbe asked to pick up a lottery chit out of the 2 chits.

This will be doneto avoid the bias.

The chits include:

1.     RTG(Right side tissue glue)

2. RSS (Right side with silk sutures)

After selectingthe chit the site to which the tissue glue to be placed will be allocatedaccordingly.

Eg : If thepatient picks selects the chit RSS  then silk sutures will be placed on the rightside and tissue glue on the left side.

SampleGrouping:

A total 30 patients(n=30) will be included, with 2 treatment sites in each, the control site andtest site which will be allocated randomly using the above mentioned lotterysystem.  (copy of method attached)

Groups

Intervention

Sample size

|Group SS (control)

Site with silk sutures

30

|Group TG (test)

Site with tissue glue

30

ARMAMENTARIUM  TO  BE  USED:

1.    Diagnostic instruments – mouth mirror, periodontalprobe, tweezer, explorer, William’s graduated probe.

2.    Cotton rolls,

3.    Gauze pieces

4.    Suction tube

5.    Surgical instruments– bard parker handle, blade no. 15C snd 12, tissue holding forcep,  periosteal elevators, set of Gracey curettes,tissue nippers, needle holder , suture cutting scissors, surgical gloves,headcap, patient’s and surgeon’s surgical drape, mouth mask.

6.    3-0 silk suture material.

7.     Ultrasonicpiezoelectric scaler.

8.     Syringes –2cc and 10cc

9.     Tissueadhesive- Isoamyl 2-cyanoacrylate

CLINICAL MEASUREMENTS**:** Following clinical measurements will be assessed -

i.        Plaque index(Sillness and Loe 1964)

ii.        Gingival index(Loe and Silness 1963)

iii.        Probing pocketdepth,

iv.        ClinicalAttachment Level, and

v.        Healing index (Landryet al) will be recorded at Baseline, 3 days, 7 days, 14 days and 3 monthspost-surgery.

vi.        Patients willalso be provided a chart to mark the pain and bleeding levels through VisualAnalog Scale.

vii.        Furthermore, timerequired for suture & sutureless flap surgery will be compared.

The subjects who satisfied the above mentioned inclusion criteria willbe seated on a dental chair and the following periodontal indices will berecorded.

 PLAQUE INDEX (Silness and Loe-1964)-  The index teeth selected will be16, 12, 24, 32,36,44. A mouth mirror and a dental explorer will be used afterair drying the teeth to assess plaque on disto-facial, mesio-facial, andlingual surfaces of the selected teeth.

 

SCORE

CRITERIA

|0

No plaque in gingival area

|1

A film of plaque adhering to the free gingival margin and adjacent area of tooth

|2

Moderate accumulation of soft deposit within the gingival pockets and/or gingival margin, or adjacent tooth surface, which can be seen by naked eyes

|3

Abundance of soft matter within the gingival margin pocket and/or on gingival margin and adjacent tooth surface.

GINGIVAL INDEX (Loe P. and Silness H.) [14] -

Teeth selected will be 16, 12, 24, 32, 36,44. The tissues surrounding each tooth will be divided into four gingivalscoring units; disto-facial papilla, facio-gingival margin, mesio-facialmargin, and the entire linguo-gingival margin. A blunt instrument such as aperiodontal probe will be used to assess the bleeding tendency of the tissues.The index for each index tooth will be reorded and then calculated by dividingtotal number of index teeth examined. This will provide gingival index for theindividual tooth.

 

SCORE

CRITERIA

|0

Absence of inflammation/ normal gingiva

|1

Mild inflammation, slight change in colour, slight edema; no bleeding on probing

|2

Moderate inflammation, moderate glazing, redness, edema and hypertrophy, bleeding on probing

|3

Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding

PROBING POCKET DEPTH (PPD) –The periodontal pocket depth will be measuredusing UNC-15 PROBE. It represents the distance between gingival margin and baseof the pocket. Average periodontal pocket depth of the person is calculated bydividing the total periodontal pocket depth by the number of teeth examined.

CLINICAL ATTACHMENT LEVEL (CAL)-

The clinical attachment level will beexamined with UNC-15 PROBE. Clinical attachment level represents distance fromcementoenamel junction to the base of gingival sulcus or periodontal pocket.Average CAL of the person is calculated by dividing the total CAL by the numberof teeth examined. It is measured from a fixed reference point (CEJ) to thebase of the pocket in mm.

HEALING INDEX (Landry et al) [15] -

|Healing index

Tissue color

Bleeding on palpation

Granulation tissue

Incision margin

Suppuration

| --- | --- | --- | --- | --- | --- | |1 - Very Poor: 2 or more signs are present

≥ 50% of red gingiva

yes

yes

not epithelialized, with loss of epithelium beyond incision margin

yes

|2 - Poor

≥ 50% of red gingiva

yes

yes

not epithelialized, with exposed connective tissue

no

|3 - Good

25 - 50% of red gingiva

no

no

no exposed connective tissue

no

|4 - Very Good

< 25% of red gingiva

no

no

no exposed connective tissue

no

|5 - Excellent

all pink tissues

no

no

no exposed connective tissue

no

INITIAL THERAPY:

The information about the need of studywill be clarified and a signed informed consent will be taken from patients.Study protocol will be approved by the Institutional Ethical Committee of PIMS(DU) Loni.

In the first visit, full mouth scalingwill be undertaken followed by root planing under local anaesthesia ifrequired. Plaque control measures will be given to the patient.

SURGICAL PROCEDURE:

Before surgical treatment, patients will be advised to swish with 0.2%chlorhexidine gluconate mouthwash. Under all aseptic precaution and condition,nerve block will be given with local anaesthesia solution of adrenalinecontaining 1:1,00,000 epinephrine.

Ø  Flapdesign- Bard-Parker number 12 and15 surgical blades will be used for reflection of full thickness flap. Forreflection of flap intra-crevicular incision will be given on buccal andlingual/ palatal aspects. To achieve primary wound closure and to preserveinterdental papillae, the incisions should be given as far inter-proximally aspossible.

Ø  Flapreflection- To gain access toalveolar bone, periosteal elevator will be used to raise full thickness flap.

Ø  Debridementand Root Surface Management- Thoroughdebridement will be carried out by removing diseased tissue from undersurfaceof flap and at the same time, proper measures should be taken to prevent theflap rupturing or papillae loss. Initial debridement will be done with handscalers and currettes (Gracey currettes, Hu-Friedy) followed by power drivenscalers. Thorough root planing will be done with hand instruments.

Ø  Procedurefor test group- After debridement, theflap will be repositioned to accomplish as much interproximal closure as possible.Isoamyl 2- cyanoacrylate will be placed in a dropwise manner on the flapmargins, held in place. The application will be done till a thin film of setcyanoacrylate is formed. No periodontal pack will be given.

Ø  Procedurefor control group- Theflap margins will be sutured with surgical silk material.

The suitable antibiotics andanalgesics will be prescribed, along with chlorhexidine digluconate rinses (0.12%)twice daily for 2 weeks. Post-operative instructions were given and patientswere informed to report after 7 days for suture removal.

Patients will be followed at 3rd day, 7th day, 14thday and 3rd month post-surgically for evaluation of clinicalmeasurements. Oral hygiene care will be given to the patient at both visits withultrasonic scaling.

STUDY PERIOD**:**

18 - 24  months starting from the time of approval ofthe study.

ETHICALAPPROVAL:

It will be made clear with the potentialsubjects that participation will be voluntary and written informed consent willbe obtained from those who agree to participate.

STATISTICALANALYSIS:

All the datawill be analyzed by applying appropriate tests of significance.

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4.     HollanderJE, Singer AJ: Laceration management. Ann Emerg Med 34:356, 1999

5.     Miller GM, Dannenbaum R, Cohen DW. A preliminaryhistologic study of the wound healing of mucogingival flaps when secured withthe cyanoacrylate tissue adhesives. J Periodontol 1974;45(8):608–618.

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10.  BarbosaFI, Corrêa DS, Zenóbio EG, Costa FO, Shibli JA. Dimensional changes betweenfree gingival grafts fixed with ethyl cyanoacrylate and silk sutures. J IntAcad Periodontol 2009;11(2):170- 6

11.  TetschP, Schoettler M. Sutureless wound closure after oral surgery. Dtsch Zahnarztl Z1972;27(3):181-5.

12.  SouzaSC, Briglia CH. Comparative study of the use of ethyl cyanoacrylate adhesiveand intracutaneous suture for cutaneous excision closure. Revista Brasileira deCirugia Plastica. 2011; 26(4):566-572.

13.  VastaniA, Maria A. Healing of intraoral wounds closed using silk sutures and isoamyl2-cyanoacrylateglue: A clinical and histological study. J Oral Maxillofac Surg.2013; 71(2):241-248.

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15.  Pippi R. Post-Surgical Clinical Monitoring ofSoft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci 2017;14(8):721-728