Effect of Gum Arabic on chronic gingivitis

• Register: ISRCTN
• Last refreshed on: 26 September 2022
• Main ID: ISRCTN14209449
• Date of registration: 02/10/2016
• Prospective Registration: Yes
• Primary sponsor: Sudan Medical Specialization Board.
• Public title: Effect of Gum Arabic on chronic gingivitis
• Scientific title: Clinical and immunological effect of Gum Arabic in patients with chronic gingivitis in Khartoum Dental Teaching Hospital, in Khartoum state in Sudan: randomised controlled trial
• Date of first enrolment: 15/10/2016
• Target sample size: 56
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14209449
• Study type: Interventional
• Study design: Double blinded, parallel, placebo, randomized clinical control trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sudan

Contacts

• Name: Arwa Gafar

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients diagnosed with generalized mild-moderate chronic plaque-induced gingivitis
2. At least twenty natural teeth must be present in the oral cavity
3. No history of periodontal therapy or previous use of antibiotics or anti-inflammatory drugs within the preceding six months will be included in the study
4. Patient fulfilling the clinical and radiographic criteria of the gingival index (Löe and Silness) >1, plaque index (Silness and Löe) >1, pocket probing depth <3 mm, clinical attachment loss = 0, with no evidence of radiographic bone loss

Exclusion criteria:
1. Patients with known allergies to the constituents of the Gum Arabic formulation
2. Hematological disorders or other systemic illness
3. Pregnant and lactating females
4. Patients undergoing orthodontic treatment
5. Patients with smoking habits


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic gingivitis
Oral Health
Chronic gingivitis

Intervention(s)

Before the start of the clinical examination, all the participants who are eligible and accepted the invitation to participate will have the objectives and the methodology of the study explained. All participates will be asked to sign a consent form outlining the goals and the procedures of the clinical trial. The acceptance from the ethical committees will be sought from the concerned bodies at the KDTH, Sudan Medical Specialization Board (SMSB) and the Federal Ministry of Health (FMOH).

Randomization and Allocation: The participates will be assigned to one of the two groups, group A (intervention group) or group B (placebo group), by restricted randomization (blocking).

1. Step one (baseline):
Clinical examination will be carried out at baseline.
Before starting the clinical assessment, each participant will be asked to gargle with saline 10 ml to remove any food debris and materia alba. Under identical conditions, an oral examination in a dental chair and light to examine the dental and periodontal status using a dental mirror and a graduated William's periodontal probe will be undertaken and scored by the candidate.
In case of exposure of blindness to the examiner (to know that the patient is assigned to the intervention group or placebo group), another dentist will undergo the follow-up clinical examinations. This clinical examiner will be calibrated to the principal examiner, and the calibration will be tested using the kappa test.
At baseline all the participants will receive thorough and meticulous scaling and polishing to remove all existing plaque, calculus deposits and extrinsic stains (will be performed by the candidate).

Each

Primary Outcome(s)

Severity of plaque build-up, measured by Plaque index of Sillness and Loe

Three measurements are taken during the study period: Baseline, after one month, after two months.

Secondary Outcome(s)

1. Severity of gingivitis, assessed using the Gingival Index of Loe and Sillness
2. Content of gingival crevicular fluid (GCF)

Three measurements are taken during the study period: Baseline, after one month, after two months.

Secondary ID(s)

905661087

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Federal Ministry of Health - National Medicines and Poisons Board review board, 25/08/2016

Results

• Results available: Yes
• Date Completed: 15/12/2016