Comparison of the Effect of Gingival Massage of Aloe-vera Gel and Sidr Honey on Chronic Periodontitis

NCT05231096 | Completed DMC

• 1 other identifier: 30071991
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Periodontitis is an inflammatory condition and a common disease worldwide. Honey has been used in dentistry for its beneficial properties. It has been used in many oral conditions like gingivitis and periodontal diseases for its antibacterial and healing properties, on the other hand, aloe vera gel is known for its anti-inflammatory aspects, and it has been used in dentistry for its potential advantages. Objective The main objective of the study was to find out the effects of gingival massage with aloe-vera gel and sidr honey as adjunct to non surgical therapy after one month in patients with Chronic periodontitis and to find out whether there is a difference in the efficacy of aloe-vera gel and sidr honey in reducing plaque index, gingival index, pocket depth and bleeding on probing after one month of gingival massage when used as adjunct to non-surgical therapy. Method 105 patients with chronic periodontitis were selected in this single-blinded Randomized control clinical trial. At recruitment non-surgical therapy i-e scaling and root debridement was performed. At baseline all clinical parameters, gingival index, plaque index, bleeding on probing and pocket depths were recorded. All the participants were then randomly divided in three groups, Group A: SRD \& Gingival massage with Aloe-vera gel, Group B: SRD \& Gingival massage with Sidr honey and Group C SRD only. On 30th day of trial all the patients were re-examined for all the clinical parameters. Statistical Analysis SPSS version 21 was used for data entry and analysis with significance level set at Ƥ \<0.05. Median, median difference and Inter Quartile ranges were reported for plaque index, gingival index, probing depth and percentages were reported for bleeding on probing. Wilcoxon Signed rank test was used for pre and post comparison. Mann Whitney test was applied for comparison between groups.

Conditions

Gingival Massage; Chronic Periodontitis

Outcome Measures

Primary Outcomes (4)

• Periodontal pocket depth

  pocket depths were measured on tooth and probing depths with 4-6mm were included.

  1 month

• Gingival index

  Score 0=Normal gingiva Score 03=Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.

  1 month

• Plaque index

  Score 0=No plaque in the gingival area. Score 03=Abundance of soft matter within the gingival pocket or on gingival margin

  1 month

• Bleeding on probing.

  recorded on each tooth and greater than 20% bleeding on probing sites were selected.

  1 month

Study Arms (3)

Group A: SRD & Gingival massage with Aloe-vera gel.

EXPERIMENTAL

Group A: Scaling and Root Debridement \& Gingival massage with Aloe-vera gel.

Other: Aloe-vera gel; Procedure: Scaling ans root Debridement

Group B: SRD & Gingival massage with Sidr honey

EXPERIMENTAL

Group B: Scaling and Root Debridement \& Gingival massage with Sidr honey

Other: sidr honey; Procedure: Scaling ans root Debridement

Group C SRD only.

OTHER

Group C Scaling and Root Debridement only.

Procedure: Scaling ans root Debridement

Interventions

Aloe-vera gel OTHER

Aloe-Vera gel Production Aloe vera gel used in this study was 98% aloe vera gel concentration and 2% normal saline. Preparation of aloe-vera gel consists of ripen leaf of aloe vera.(26) Aloe vera leaf was washed thoroughly under water and then cut from the center and the seeping gel was collected in sterile container and was stored at 4°C until the time of application. In our research this pure Aloe vera gel was extracted by The Pakistan Council of Scientific \& Industrial Research (PCSIR) laboratory.

Group A: SRD & Gingival massage with Aloe-vera gel.

sidr honey OTHER

Honey collection Sidr (Beri) honey was used in this study. Honey was thick, raw and cold extracted from remote Pakistan afghan tribal forest belt of Sidr trees. It was smooth, viscous and medium to dark amber in color.

Group B: SRD & Gingival massage with Sidr honey

Scaling ans root Debridement PROCEDURE

non-surgical periodontal therapy was given to all the participants of all the three groups

Group A: SRD & Gingival massage with Aloe-vera gel.; Group B: SRD & Gingival massage with Sidr honey; Group C SRD only.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/ female, 35-65 years of age with minimal 5 natural teeth in each quadrant excluding 3rd molars.
• Patients having Chronic Periodontitis with probing depth ≥ 4 to 6mm and bleeding on probing in greater than 20% sites.
• Systematically healthy.

You may not qualify if:

• Individuals who smoke.
• Any addiction of Areca nuts, gutka, paan or alcohol.
• Individuals with any systemic diseases like diabetes mellitus, cardiovascular, endocrine as they may affect the outcome of research.
• Women with pregnancy/lactation.
• Individuals with any known allergy from aloe-vera or honey.
• Systemic or topical use of antibiotic in past 6 months.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr Fizza

Karachi, Sindh, 12345, Pakistan

Location

Related Publications (1)

• Khalid F, Ahmed S, Farooqui WA, Pervaiz H, Riaz S, Shabbir S, Ghazal M, Khan ZR. Clinical Assessment of the Efficacy of Natural Nutraceuticals in Gingival Massage Therapy: A Randomized Clinical Study. Int J Dent Hyg. 2025 Dec 10. doi: 10.1111/idh.70014. Online ahead of print.

  PMID: 41373073 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Aloe vera gel

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates the outcomes was masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 105 patients with chronic periodontitis were selected in this single-blinded Randomized control clinical trial. At recruitment non-surgical therapy i-e scaling and root debridement was performed. At baseline all clinical parameters, gingival index, plaque index, bleeding on probing and pocket depths were recorded. All the participants were then randomly divided in three groups, Group A: SRD \& Gingival massage with Aloe-vera gel, Group B: SRD \& Gingival massage with Sidr honey and Group C SRD only. On 30th day of trial all the patients were re-examined for all the clinical parameters.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 9, 2022
• Study Start: September 3, 2019
• Primary Completion: June 12, 2020
• Study Completion: October 15, 2020
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

PA (1)