The Effects of Palatal Pre-sutures in Connective Tıssue Graft Surgery

NCT05395923 | Completed

• 1 other identifier: 2015-KAEK-58-22-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Connective tissue graft operation is one of the most frequently performed surgical procedures to increase the width of the attached gingiva and to treat gingival recessions. The most preferred donor site during this operation is the palatal mucosa.Reported postoperative complications are usually related to the donor site. Problems such as prolongation of bleeding time, delay in wound healing and severe pain in the palatal region where the graft is taken are frequently encountered. Bleeding control in the palatal donor area is very important for patient comfort. Additional measures may be required to control bleeding, such as sutures with or without hemostatic agents, or acrylic, plastic palatal stents and periodontal pastes prepared before the operation. Suturing the Greater Palatine Artery (GPA) or terminal vessel branches has been shown to be an effective method to control palatal bleeding. Therefore the aim of this study is to evaluate the effectiveness of the pre-suture method applied in the palatal region before the connective tissue graft is taken in reducing hemostasis.Pre-suture method can increase the operator's field of vision and operational comfort. Patient-reported outcomes such as the amount of pain and bleeding in the palatal donor area during and after surgery, painkiller intake, number of days of discomfort, satisfaction, quality of life, and willingness to be treated will be evaluated. In addition, it will be evaluated whether this suture technique affects the healing of the half-thickness flap in the palatal region after obtaining a connective tissue graft with a single incision method.

Conditions

Gingival Recession; Bleeding Hemorrhage; Suture, Complication

Outcome Measures

Primary Outcomes (11)

• Measuring the Amount of Intra-operative Bleeding with a Precision Balance

  In our study, the amount of blood lost will be estimated by using the gauze weight method, which is a method of directly estimating blood loss. All measurements will be made on a 1 g precision digital balance. Sterile gauze swabs will be weighed dry before the operation. The gauze pads that will be used later will be moistened with 10 mL of sterile 0.9 g/L saline solution before starting the procedure and the weight will be measured again. The time from the removal of the connective tissue graft to the end of the operation will be measured and the pre-moistened gauze pads will be used on the palate during this period and will be stored separately and their weight will be measured immediately after the operation is over. In this method, aspiration in the palatal region should be avoided to minimize errors in blood loss measurement.

  During surgery

• Reporting of secondary bleeding as present/absent in the 1st postoperative week

  Reporting of secondary bleeding as present/absent both by the patient and by the physician in the follow-up appointments in the 1st postoperative weeks

  1st postoperative week after the operation.

• patient discomfort and satisfaction [Oral Health Impact Profile ]

  In this evaluation, the Oral Health Impact Profile (OHIP-14) test will be used by marking the patients on the 3rd postoperative day. Likert response system in the evaluation of the OHIP14 scale: 0: "never", 1. "very little" 2. "sometimes" 3. "quite often" 4. is rated as "often". The total score of the answers given by the participant to each item is evaluated by calculating. The total score is minimum 0, maximum 56. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases.

  On the 3rd day after the operation.

• Evaluation of the pain felt by the patients after the operation with Visual Analogue Scale

  Pain scores will be recorded on the postoperative 3rd day. It is determined by the patient's assessment of the intensity of pain felt on a scale from 0 to 10. 0: No pain, 10: There is unbearable pain.

  3rd day after the operation.

• Reporting of secondary bleeding as present/absent in the 2nd postoperative week

  Reporting of secondary bleeding as present/absent both by the patient and by the physician in the follow-up appointments in the 2nd postoperative weeks

  2nd postoperative week after the operation.

• patient discomfort and satisfaction [Oral Health Impact Profile ]

  In this evaluation, the Oral Health Impact Profile (OHIP-14) test will be used by marking the patients on the 1st postoperative week. Likert response system in the evaluation of the OHIP14 scale: 0: "never", 1. "very little" 2. "sometimes" 3. "quite often" 4. is rated as "often". The total score of the answers given by the participant to each item is evaluated by calculating. The total score is minimum 0, maximum 56. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases.

  1st week after the operation.

• patient discomfort and satisfaction [Oral Health Impact Profile ]

  In this evaluation, the Oral Health Impact Profile (OHIP-14) test will be used by marking the patients on the 2nd postoperative week. Likert response system in the evaluation of the OHIP14 scale: 0: "never", 1. "very little" 2. "sometimes" 3. "quite often" 4. is rated as "often". The total score of the answers given by the participant to each item is evaluated by calculating. The total score is minimum 0, maximum 56. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases.

  2nd week after the operation.

• patient discomfort and satisfaction [Oral Health Impact Profile ]

  In this evaluation, the Oral Health Impact Profile (OHIP-14) test will be used by marking the patients on the 4th postoperative week. Likert response system in the evaluation of the OHIP14 scale: 0: "never", 1. "very little" 2. "sometimes" 3. "quite often" 4. is rated as "often". The total score of the answers given by the participant to each item is evaluated by calculating. The total score is minimum 0, maximum 56. It is concluded that as the total score increases, the severity of the problem increases and the quality of life decreases.

  4th week after the operation.

• Evaluation of the pain felt by the patients after the operation with Visual Analogue Scale

  Pain scores will be recorded on the postoperative 1st week by marking the Visual Analogue Scale (VAS). It will be determined on a scale from 0 (no pain) to 10 (unbearable pain). It is determined by the patient's assessment of the intensity of pain felt on a scale from 0 to 10. 0: No pain 10: There is unbearable pain

  1st week after the operation.

• Evaluation of the pain felt by the patients after the operation with Visual Analogue Scale.

  Pain scores will be recorded on the postoperative 2nd week by marking the Visual Analogue Scale (VAS). It will be determined on a scale from 0 (no pain) to 10 (unbearable pain). It is determined by the patient's assessment of the intensity of pain felt on a scale from 0 to 10. 0: No pain, 10: There is unbearable pain.

  2nd week after the operation.

• Evaluation of the pain felt by the patients after the operation with Visual Analogue Scale

  Pain scores will be recorded on the postoperative 4th week by marking the Visual Analogue Scale (VAS). It will be determined on a scale from 0 (no pain) to 10 (unbearable pain). It is determined by the patient's assessment of the intensity of pain felt on a scale from 0 to 10. 0: No pain, 10: There is unbearable pain.

  4th week after the operation.

Secondary Outcomes (8)

• Evaluation of palatal wound healing by measuring the Early Wound Healing Index in the first 3 months after the operation

  3rd day after surgery.

• Findings of necrosis on the donor area

  During and first 3 months after surgery

• Findings of healing with complications on the donor area

  During and first 3 months after surgery

• Evaluation of palatal wound healing by measuring the Early Wound Healing Index

  1st week after surgery.

• Evaluation of palatal wound healing by measuring the Early Wound Healing Index

  2nd week after surgery.

Study Arms (2)

Palatal Pre-Suture (GPCS)

EXPERIMENTAL

In the test group, GPCS (Silk, 4-0, 18 mm, 3/8 sharp needle) will be placed before the incision in the palatal region. GPCS will be taken one week after surgery.

Procedure: Suture

No Palatal Suture (No GPCS) - Control

ACTIVE COMPARATOR

In the control group, no sutures will be applied before graft harvesting from the palate.

Procedure: No Suture CTG -Control

Interventions

Suture PROCEDURE

The pressure application will be applied before the incision on the palate.

Palatal Pre-Suture (GPCS)

No Suture CTG -Control PROCEDURE

A graft will be taken from the palate before the procedure is applied.

No Palatal Suture (No GPCS) - Control

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- The patient must be over the age of 18,
• Not having any systemic disease,
• Not receiving chemotherapy or radiotherapy treatment,
• Not using drugs regularly and not being addicted to drugs,
• Not be in pregnancy and/or lactation period,
• Not smoking,
• Not having received antibiotic treatment in the last 6 months,
• Presence of Cairo Type 1 or Type 2 recession defect in a single tooth,
• The patient is cooperative.

You may not qualify if:

• The patient is younger than 18 years old,
• Active infectious disease (acute hepatitis, AIDS, tuberculosis), cancer or any systemic condition that may affect periodontal tissues,
• Receiving chemotherapy or radiotherapy treatment,
• Being on regular medication and being addicted to drugs,
• Patients with a plaque score greater than 20% after phase I treatment (Silness and Löe, 1964),
• Being in pregnancy and/or lactation period,
• Being a smoker
• To have been treated with antibiotics in the last 6 months,
• Not being cooperative.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession; Hemorrhage

Interventions

Sutures

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Burcu Karaduman

  bkaraduman@biruni.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: May 27, 2022
• Study Start: January 9, 2023
• Primary Completion: April 29, 2024
• Study Completion: July 29, 2024
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)