Periodontal PocketNCT06119893
The Use of Submucosal Dexamethasone After Periodontal Surgery
A study testing submucosal 8 mg (2 mL) dexamethasone application and submucosal 2 mL 0.9% isotonic sodium chloride application in people with Periodontal Pocket and Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Pain, Swelling/ Edema
- What is being tested?
- submucosal 8 mg (2 mL) dexamethasone application and submucosal 2 mL 0.9% isotonic sodium chloride application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2021to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pocket depth ≥5mm;
- systemically healthy;
- without drug allergy;
- without any blood disease;
- not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
- received no any periodontal surgery in the last 6 months;
Who cannot join
- poor oral hygiene;
- smoking;
- any systemic disease that would affect the surgical operation;
- problem with the kidneys or adrenal glands;
- connective tissue disease or immunodeficiency;
- breastfeeding period or pregnancy.
- high dental anxiety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery
Read the detailed description
Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs.
Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.
- Conditions
- Periodontal Pocket, Pain, Swelling/ Edema, Patient Satisfaction, Periodontitis
- Being tested
- submucosal 8 mg (2 mL) dexamethasone application, submucosal 2 mL 0.9% isotonic sodium chloride application
- Keywords
- pain, dexamethasone, surgical flaps
- Medical subject headings
- Periodontal Pocket, Pain, Edema, Patient Satisfaction, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
submucosal 8 mg (2 mL) dexamethasone applicationDrug
Also called Periodontal flap surgery
The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.
submucosal 2 mL 0.9% isotonic sodium chloride applicationDrug
Also called Periodontal flap surgery
The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the control group, 2 mL 0.9% isotonic sodium chloride (saline) with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation Receives: Drug: submucosal 2 mL 0.9% isotonic sodium chloride application |
| Test Group | Active comparator | Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the test group, 8 mg (2 mL) submucosal dexamethasone with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation Receives: Drug: submucosal 8 mg (2 mL) dexamethasone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scale (VAS) was assessed to monitor the degree of pain.VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain),
Measured: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
NRS-101
101-point numeric rate scale (NRS-101) was assessed to monitor the degree of pain. NRS-101 is a 101-point numerical ratio scale that rates pain severity from 0 to 100. (0 = no pain to 100 = severe pain),
Measured: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
Swelling
Linear measurements were taken for swelling with a millimeter tape measure. Measurements were made between the angle of the mandible and the mentus, labial commissure, nasal ala, outer corner of the eye and tragus. The average of these five measurements was noted.
Measured: Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
Secondary outcomes (6)
Trismus
For trismus evaluation, mouth opening was measured using a millimetric ruler by measuring the distance between the mesial-incisal corners of the upper right and lower right central incisors at the maximum jaw opening while the patient was sitting upright.
Measured: It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation
Chewing efficiency
Chewing efficiency was scored by the patients as 1) very poor, 2) poor, 3) good, 4) very good and 5) excellent.
Measured: It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation
Healing of operation area
Healing at the operative site in terms of infection was scored by clinician as follows: 1) very poor, 2) poor, 3) good, 4) very good, and 5) excellent healing
Measured: It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation
Discomfort
In the evaluation of discomfort, the four-point verbal rating scale (VRS-4) and a questionnaire questioning patient comfort were used. The questionnaire was scored with this four-point scoring system (Pain in this scoring: 1) none, 2) mild, 3) moderate, 4) severe).
Measured: It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation
Analgesics consumed
The number of analgesics used was noted by the patient in the pain diary.
Measured: The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary
General satisfaction
On the day of removing suture, the patients' general satisfaction levels were measured with a 5-point scale ( 1) poor, 2) reasonable, 3) good, 4) very good and 5) excellent).
Measured: 14th day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Aug 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dicle Altındal, Yuzuncu Yil University
- Investigators
- Dicle Altindal, DDS, Principal investigator, Yuzuncu Yil UniversityAnas ALSAFADI, PhD, Study chair, Special dental clinicBasem ALSHUJAA, PhD, Study chair, Special dental clinicAhmet Cemil Talmac, PhD, Study chair, Yuzuncu Yil UniversityBilal Ege, PhD, Study chair, Adiyaman UniversityMetin Calisir, PhD, Study chair, Adiyaman UniversityNazli Zeynep Alpaslan, PhD, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119893
- Sponsor's protocol ID
- 13.07.2021/08
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vieth MP, Deas DE, Archontia Palaiologou A, Diogenes A, Mader MJ, Mealey BL. Effect of intravenous dexamethasone on postoperative pain and swelling following periodontal flap surgery: A randomized controlled trial of patient-centered outcomes. J Periodontol. 2022 Feb;93(2):237-245. doi: 10.1002/JPER.21-0153. Epub 2021 Jun 3.
PubMed 34021915Steffens JP, Santos FA, Pilatti GL. Postoperative periodontal pain prevention using two dexamethasone medication protocols: a double-blind, parallel-group, placebo-controlled randomized clinical trial. Am J Dent. 2011 Dec;24(6):354-6.
PubMed 22263332Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.
PubMed 31702056Altindal D, Alsafadi A, Alshujaa B, Talmac AC, Ege B, Calisir M, Alpaslan NZ. Effect of submucosal dexamethasone on postoperative pain, swelling and trismus after periodontal surgery: a randomized clinical study. Clin Oral Investig. 2024 Dec 4;28(12):681. doi: 10.1007/s00784-024-06076-5.
PubMed 39627624
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06119893
- Acronym / sponsor ID
- 13.07.2021/08
- Conditions
- Periodontal Pocket, Pain, Swelling/ Edema, Patient Satisfaction, Periodontitis
- Keywords
- pain, dexamethasone, surgical flaps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery
Detailed description
Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs.
Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: submucosal 2 mL 0.9% isotonic sodium chloride applicationPatient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the control group, 2 mL 0.9% isotonic sodium chloride (saline) with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation |
| Test Group | Active comparator | Drug: submucosal 8 mg (2 mL) dexamethasone applicationPatient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the test group, 8 mg (2 mL) submucosal dexamethasone with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pocket depth ≥5mm;
- systemically healthy;
- without drug allergy;
- without any blood disease;
- not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
Key exclusion criteria (7 listed)
- poor oral hygiene;
- smoking;
- any systemic disease that would affect the surgical operation;
- problem with the kidneys or adrenal glands;
- connective tissue disease or immunodeficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| submucosal 8 mg (2 mL) dexamethasone applicationAlso: Periodontal flap surgeryThe mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group. | Drug | Test Group |
| submucosal 2 mL 0.9% isotonic sodium chloride applicationAlso: Periodontal flap surgeryThe mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group | Drug | Control Group |
Primary outcome
VAS
Time frame: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
Visual analogue scale (VAS) was assessed to monitor the degree of pain.VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain),
NRS-101
Time frame: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days
101-point numeric rate scale (NRS-101) was assessed to monitor the degree of pain. NRS-101 is a 101-point numerical ratio scale that rates pain severity from 0 to 100. (0 = no pain to 100 = severe pain),
Swelling
Time frame: Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
Linear measurements were taken for swelling with a millimeter tape measure. Measurements were made between the angle of the mandible and the mentus, labial commissure, nasal ala, outer corner of the eye and tragus. The average of these five measurements was noted.
6 secondary outcomes
Trismus
Time frame: It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation
Chewing efficiency
Time frame: It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation
Healing of operation area
Time frame: It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation
Discomfort
Time frame: It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation
Analgesics consumed
Time frame: The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary
General satisfaction
Time frame: 14th day after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 34021915Vieth MP, Deas DE, Archontia Palaiologou A, Diogenes A, Mader MJ, Mealey BL. Effect of intravenous dexamethasone on postoperative pain and swelling following periodontal flap surgery: A randomized controlled trial of patient-centered outcomes. J Periodontol. 2022 Feb;93(2):237-245. doi: 10.1002/JPER.21-0153. Epub 2021 Jun 3.
- Background: PubMed 22263332Steffens JP, Santos FA, Pilatti GL. Postoperative periodontal pain prevention using two dexamethasone medication protocols: a double-blind, parallel-group, placebo-controlled randomized clinical trial. Am J Dent. 2011 Dec;24(6):354-6.
- Background: PubMed 31702056Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.
- Derived from this study: PubMed 39627624Altindal D, Alsafadi A, Alshujaa B, Talmac AC, Ege B, Calisir M, Alpaslan NZ. Effect of submucosal dexamethasone on postoperative pain, swelling and trismus after periodontal surgery: a randomized clinical study. Clin Oral Investig. 2024 Dec 4;28(12):681. doi: 10.1007/s00784-024-06076-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dicle Altindal, DDS principal investigator
Yuzuncu Yil University
Anas ALSAFADI, PhD study chair
Special dental clinic
Basem ALSHUJAA, PhD study chair
Special dental clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing submucosal 8 mg (2 mL) dexamethasone application and submucosal 2 mL 0.9% isotonic sodium chloride application in people with Periodontal Pocket and Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119893, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.