RESEARCH QUESTION-

Which one amongst the tissue glue and silk suture will have a better periodontal health outcome in periodontitis patients?

RESEARCH HYPOTHESIS-

Directional hypothesis- Tissue glue will be better than silk sutures in terms of periodontal health outcomes in periodontitis patients.

Non-Directional hypothesis- There will be no difference in tissue glue and silk sutures in terms periodontal health outcomes in periodontitis patients.

AIM OF THE STUDY:

  The aim of this study is to compare the effectiveness of flap closure with silk sutures and tissue glue (bioadhesive material).

OBJECTIVES OF THE STUDY:

  To determine the effectiveness of tissue glue with braided silk sutures after a periodontal flap surgery on the basis of parameters-

Ø  Indices (plaque index, gingival index, healing index)

Ø  PPD (Probing Pocket Depth)

Ø  CAL (Clinical Attachment Level)

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

Ø  Time required for completion of suturing during periodontal flap surgery.

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

MATERIALS AND METHODS:

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

STUDY DESIGN:

Study Type                  :  Experimental.

Study Design               :  Phase IV Randomized Clinical Trial

Period of Study            :  2 years

Study Start Date           :  May 2022 (after the IEC approval)

Setting                          :  Department of Periodontology, Rural Dental Hospital, Loni.

 The subjects will be randomly assigned to two treatment groups for deciding the effectiveness of silk sutures and tissue glue after periodontal flap surgery.

INCLUSION CRITERIA

1.     Adults aged between 31 to 60 years.

2.     Patients with probing depth ≥5mm.

3.     Patient ready to give informed consent.

4.     Patients of both genders.

5.     Patients ready to come for follow-ups.

EXCLUSION CRITERIA

1.     Any systemic illness known to affect the outcome of periodontal therapy.

2.     Allergic reactions to tissue glue.

3.     Pregnant and lactating women.

4.     Use of tobacco / smoking in any form.

5.     Patients under anticoagulation treatment or bleeding disorder. 

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

METHODOLOGY:

All patients satisfying the above inclusion and exclusion criteria will be given a unique code and subjected to a well-defined random allocation method.

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

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

This will be done to avoid the bias.

The chits include:

1.     R_TG (Right side tissue glue)

2. R_SS (Right side with silk sutures)

After selecting the chit the site to which the tissue glue to be placed will be allocated accordingly.

Eg : If the patient picks selects the chit R_SS  then silk sutures will be placed on the right side and tissue glue on the left side.

Sample Grouping:

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

ARMAMENTARIUM  TO  BE  USED:

1.     Diagnostic instruments – mouth mirror, periodontal probe, 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.      Ultrasonic piezoelectric scaler.

8.      Syringes – 2cc and 10cc

9.      Tissue adhesive- 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 pocket depth,

   iv.         Clinical Attachment Level, and

     v.         Healing index (Landry et al) will be recorded at Baseline, 3 days, 7 days, 14 days and 3 months post-surgery.

   vi.         Patients will also be provided a chart to mark the pain and bleeding levels through Visual Analog Scale.

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

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

PLAQUE INDEX (Silness and Loe-1964)-  The index teeth selected will be 16, 12, 24, 32,36,44. A mouth mirror and a dental explorer will be used after air drying the teeth to assess plaque on disto-facial, mesio-facial, and lingual surfaces of the selected teeth.

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 gingival scoring units; disto-facial papilla, facio-gingival margin, mesio-facial margin, and the entire linguo-gingival margin. A blunt instrument such as a periodontal 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 dividing total number of index teeth examined. This will provide gingival index for the individual tooth.

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

CLINICAL ATTACHMENT LEVEL (CAL)-

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

HEALING INDEX (Landry et al) ^[15] -

INITIAL THERAPY:

    The information about the need of study will 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 scaling will be undertaken followed by root planing under local anaesthesia if required. 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 adrenaline containing 1:1,00,000 epinephrine.

Ø  Flap design- Bard-Parker number 12 and 15 surgical blades will be used for reflection of full thickness flap. For reflection of flap intra-crevicular incision will be given on buccal and lingual/ palatal aspects. To achieve primary wound closure and to preserve interdental papillae, the incisions should be given as far inter-proximally as possible.

Ø  Flap reflection- To gain access to alveolar bone, periosteal elevator will be used to raise full thickness flap.

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

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

Ø  Procedure for control group- The flap margins will be sutured with surgical silk material.

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

        Patients will be followed at 3^rd day, 7^th day, 14^th day and 3^rd month post-surgically for evaluation of clinical measurements. Oral hygiene care will be given to the patient at both visits with ultrasonic scaling.

STUDY PERIOD:

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

ETHICAL APPROVAL:

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

STATISTICAL ANALYSIS:

All the data will be analyzed by applying appropriate tests of significance.

References:

1.     Raitapuro-Murray T, Molleson TI, Hughes FJ. The prevalence of periodontal disease in a Romano-British population c 200-400 AD. Br dent J. 2014;217:459-66.

2.     Newman MG, Carranza FA, Takei H, Klokkevold PR. Carranzas clinical periodontology. 10^th ed. Elsevier health sciences; 2006.

3.     Takei HH, Carranza FA, Jonathan H. Do: the periodontal flap ed. T, Newman C, Klokkevold Textbook of Carranza’s clinical periodontology. Elsevier; 2015. pp.582–586.

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

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

6.     Coover HW, Joyner FB, Shearer NH, Wicker TH. Chemistry and performance of cyanoacrylate adhesives. J Soc Plast Eng 1959;15(4):13-7.

7.      Kumar MS, Natta S, Shankar G, Reddy SH, Visalakshi D, Seshiah GV. Comparison between Silk Sutures and Cyanoacrylate Adhesive in Human Mucosa- A Clinical and Histological Study. Journal of International Oral Health. 2013; 5(5):95-10c

8.     Ellis DA, Shaikh A. The ideal tissue adhesive in facial plastic and reconstructive surgery. J Otolaryngol 1990;19(1):68-72

9.     Tse DT, Panje WR, Anderson RL. Cyanoacrylate adhesive used to stop CSF leaks during orbital surgery. Arch Ophthalmol 1984;102(9):1337-9.

10.  Barbosa FI, Corrêa DS, Zenóbio EG, Costa FO, Shibli JA. Dimensional changes between free gingival grafts fixed with ethyl cyanoacrylate and silk sutures. J Int Acad Periodontol 2009;11(2):170- 6

11.  Tetsch P, Schoettler M. Sutureless wound closure after oral surgery. Dtsch Zahnarztl Z 1972;27(3):181-5.

12.  Souza SC, Briglia CH. Comparative study of the use of ethyl cyanoacrylate adhesive and intracutaneous suture for cutaneous excision closure. Revista Brasileira de Cirugia Plastica. 2011; 26(4):566-572.

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

14.  Löe H. The gingival index, the plaque index and the retention index systems. The Journal of Periodontology. 1967 Nov;38(6):610-6.

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