ISRCTN ISRCTN14209449
DOI https://doi.org/10.1186/ISRCTN14209449
Secondary identifying numbers 905661087
Submission date
07/09/2016
Registration date
02/10/2016
Last edited
13/09/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Gum Arabic (GA) is a natural product which has been used for centuries as a traditional oral hygiene substance in Arabian and African countries. Many studies have been run that support the potential activity of GA as an antiplaque agent; it is thought that it may act to prevent dental plaque formation. The present study was designed to test the effect of GA on chronic gingivitis, to assess the effect of introducing GA to a group of patients to see whether it reduces plague formation and gingivitis and compare the progress of gingivitis between a group who are given GA and a group that is given a placebo (dummy) gum. It also wants to test whether the presence of a protein called Interleukin 1 beta (IL-1β) can predict whether gum (periodontal) disease is progressing.

Who can participate?
Adults with mild to moderate gingivitis.

What does the study involve?
Participants are randomly allocated to one of two groups. After brushing their teeth, those in group 1 are asked to apply half a teaspoon of GA gently by finger to the border line between teeth and gums - the so-called dentogingival area – for around and hour and then leave it for five minutes before washing with water. Similarly, after brushing their teeth, participants in group 2 are asked to apply half a teaspoon of placebo powder gently by finger to the dentogingival area for around and hour and then leave it for five minutes before washing with water. All participants in both groups are asked to otherwise follow their usual regular oral hygiene habits. A gum disease assessment is carried out for all participants one month later and repeated after two months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Khartoum Dental Teaching Hospital (Sudan)

When is the study starting and how long is it expected to run for?
October 2016 to December 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Nazik Nurelhuda
n.nurelhuda@hotmail.co.uk
2. Dr Arwa Gafar
arwajafer@gmail.com

Contact information

Dr Arwa Gafar
Scientific

PO Box 1550
Khartoum North
13311
Sudan

ORCiD logoORCID ID 0000-0002-4355-4762
Phone +249905661087
Email arwajafer@gmail.com
Dr Nazik Nurelhuda
Scientific

PO Box 1550
Khartoum North
13311
Sudan

ORCiD logoORCID ID 0000-0003-4580-1744
Phone 00249912725479
Email n.nurelhuda@hotmail.co.uk

Study information

Study designDouble blinded, parallel, placebo, randomized clinical control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleClinical and immunological effect of Gum Arabic in patients with chronic gingivitis in Khartoum Dental Teaching Hospital, in Khartoum state in Sudan: randomised controlled trial
Study objectivesGeneral objectives:
To evaluate the effect of Gum Arabic (GA) on chronic gingivitis.

Specific objectives:
1. To assess the periodontal health status (GI, PI) of a population of the study at Khartoum Dental Teaching Hospital (KDTH)
2. To assess the effect of introducing GA to a group of patients with gingivitis at baseline on the following clinical indicators: PI, GI and immunological indicator (IL-1 β)
3. To compare the progress of gingivitis between a group who received GA versus a group who received placebo treatment
4. To assess the ability of IL-1β as predictor of periodontal disease progression
Ethics approval(s)Federal Ministry of Health - National Medicines and Poisons Board review board, 25/08/2016
Health condition(s) or problem(s) studiedChronic gingivitis
InterventionBefore 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 participant will then be randomly assigned to one of the two groups by the assistant:

Group 1: Participants are asked to apply half of teaspoon quantity of the Gum Arabic (GA) formula gently by finger to the dentogingival area for about an hour following tooth brushing and to leave application for five minutes before washing with normal water. Regular use in the morning and evening after one hour from regular brushing will be advised.
Group 2: Participants will be asked to apply half of teaspoon quantity of a placebo formula gently by finger to the dentogingival area for about an hour following tooth brushing and to leave application for five minutes before washing with normal water. Regular use in the morning and evening after one hour from regular brushing will be advised.

All participants will be asked to maintain their regular oral hygiene habits. Also, no prophylaxis will be carried out preceding the onset of the study on the participants. All of the participants will receive the sealed containers (150 g), and they are also blinded to the type of the formula (either GA or placebo). They will be instructed by the assistant not to share any information with the examiner to ensure blindness.

2. Step two (after one month):
The periodontal status of all of the participants will be assessed (by the candidate) using the same clinical parameters (GI, PI) and GCF also will be collected by the same tools. All of the participants will be referred to the assistant to give them the remaining of the formulas (300 g) for rest of the study.

3. Step three (after two months):
All of the procedures which have been conducted at the fourth week will be repeated and final periodontal assessment will be carried out.
Intervention typeOther
Primary outcome measureSeverity 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 measures1. 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.
Overall study start date15/10/2016
Completion date15/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsSample size calculation: Sample size was calculated using openepi.com, using the equation for RCT, assuming a two sided confidence interval of 95%, power of 80%, ration of exposed to unexposed in the sample of 1:1, and a percentage of 35% of the exposed to have an improved GI and PI by the end of the study. Total sample size (Kelsey calculation) of 56, 28 in each group. To overcome withdrawal of patients we raise the sample size to 60.
Total final enrolment60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/10/2016
Date of final enrolment15/12/2016

Locations

Countries of recruitment

  • Sudan

Study participating centre

Khartoum Dental Teaching Hospital
13311
Sudan

Sponsor information

Sudan Medical Specialization Board.
University/education

Khartoum Downtown
Khartoum Hospital Street
Khartoum
13311
Sudan

Phone +249912164855
Email info@smsb.gov.sd
Website http://www.smsb.gov.sd/en/
ROR logo "ROR" https://ror.org/02ts9m233

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date15/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe authors intend to publish the article with the results. The target journal is yet to be confirmed.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 13/06/2022 13/09/2022 Yes No

Editorial Notes

13/09/2022: Publication reference and total final enrolment added.
11/10/2016: Internal review