Alveolar Ridge Preservation Using Acemannan Aloe Vera Versus Natural Socket Healing

Cairo University26 enrolled

Overview

The goal of this clinical trial is to evaluate the effectiveness of acemannan aloe vera powder extract in preserving the alveolar ridge following tooth extraction in healthy adult patients. It will also assess the healing process by radiographic and histomorphometric analyses. The main questions it aims to answer are: Does acemannan aloe vera powder extract improve alveolar ridge preservation compared with natural socket healing? Does the use of acemannan aloe vera powder extract enhance bone quality and new bone formation as assessed by radiographic and histomorphometric outcomes? Researchers will compare sockets treated with acemannan aloe vera powder extract to sockets allowed to heal naturally to determine whether the intervention results in improved dimensional preservation of the alveolar ridge and enhanced bone regeneration. Participants will: Undergo tooth extraction according to the study protocol. Be randomly assigned to receive either acemannan aloe vera powder extract for alveolar ridge preservation or natural socket healing without grafting. Attend scheduled follow-up visits for clinical and radiographic evaluations. Undergo radiographic assessment using cone-beam computed tomography (CBCT) to evaluate changes in alveolar ridge dimensions. Provide a bone biopsy at the time of implant placement for histomorphometric analysis of new bone formation and tissue composition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Socket Preservation

Interventions

Aloe vera extractBIOLOGICAL

After atraumatic tooth extraction and socket debridement, the Aloe vera mixture was then prepared by combining a 500 mg of Aloe vera powder , equivalent to approximately ¼ teaspoon, with 2 ml of sterile saline (Nimma et al., 2017). The mixture was immediately applied into the extraction socket and gently condensed using a bone graft condenser. A collagen plug was carefully placed above the Aloe vera mixture in the socket, ensuring close contact with all socket walls. Finally, the site was closed and stabilized using Vicryl 5-0 resorbable sutures to secure the collagen plug and support proper healing during the early postoperative phase .

Normal Socket HealingOTHER

Control Group: Normal Socket Healing * Tooth Extraction: Standard tooth extraction procedures will be followed, ensuring minimal trauma to the surrounding bone and soft tissues. * Socket Cleaning: The extraction socket will be thoroughly cleaned and debrided to remove any debris and blood clots. * Natural Healing: The socket will be allowed to heal naturally without any additional intervention. Standard post-extraction care will be provided.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Non-restorable tooth in maxillary or mandibular anterior esthetic region. * Intact or minimally affected buccal plate of bone. * Patients at least 18 years or older. * Motivated patients, agree to sign the written informed consent and complete the follow-up period. Exclusion Criteria: * Infection at the extraction site. * Smokers more than 10 cigarettes per day . * Patients undergoing or having a history of radiotherapy, chemotherapy, or bisphosphonate therapy . * Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism) . * Patients on medication that may interfere with healing (Corticosteroids, Bisphosphonate, Chemo/radio therapy) * Systemic diseases or medications that affect blood clotting * Pregnant females or those planning to get pregnant during the study period (American Dental Association, 2011).

Outcomes

Primary Outcomes

Change in radiographic horizontal ridge width at 4 mm below the most coronal aspect of the crest

The immediate postoperative scans served as the baseline and were evaluated after 6 months to assess horizontal ridge width. Employing the same software, standardized measurements were obtained at both time points using consistent anatomical landmarks. On each baseline and after 6 months images, the apical point of the extraction socket was identified, and a vertical line was drawn through the socket's midpoint. A horizontal reference line perpendicular to the vertical axis was then established at the apical point. Horizontal ridge width was measured at 4 mm below the crest, yielding the parameters HW-4

Time frame: 6 months postoperatively

Secondary Outcomes

Horizontal ridge width was measured at 2 mm and 6 mm below the crest

The immediate postoperative scans served as the baseline and were evaluated after 6 months to assess horizontal ridge width. Employing the same software, standardized measurements were obtained at both time points using consistent anatomical landmarks. On each baseline and 6-month image, the apical point of the extraction socket was identified, and a vertical line was drawn through the socket's midpoint. A horizontal reference line perpendicular to the vertical axis was then established at the apical point. Horizontal ridge width was measured at 2 mm and 6 mm below the crest, yielding the parameters HW-2 and HW-6, respectively

Time frame: 6 months postoperatively

Vertical ridge height

DICOM files of the Immediate Post-Operative scans were assessed as a baseline and 6 months postoperatively for measurements of Change in radiographic buccal \& palatal ridge height. DICOM files of the two post-operative scans were assessed using a specialized software program, OnDemand® Software for Secondary outcome measurements.Two reference lines were drawn. The vertical reference line was placed at the midpoint of the extraction socket, intersecting the apical reference point. The height of the alveolus was measured at the midbuccal aspect (BH) and midlingual aspect (LH).

Time frame: 6-months post

Percentage of new vital bone formation

After 6 months healing a local anesthesia will be given, a full thickness mucoperiosteal flap will be detached in the augmented areas and a bone biopsy will be collected using a 2 mm trephine bur.

Time frame: 6 months post