A new technique for better healing of patients seeking oral rehabilitation with implants

Not Applicable

• Conditions: Partially edentulous patients requiring guided bone regeneration; Oral Health

• Registration Number: ISRCTN10220098
• Lead Sponsor: Instituto Superior de Ciências da Saúde Egas Moniz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-05
• Last Update Posted: 15 May 2023
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Systemically healthy
2.?=?21?years of age
3. Partially edentulous in the maxilla with 1-2 missing teeth
4. Insufficient ridge width (<5?mm), no evidence of vertical loss
5. Adequate soft tissue phenotype (=2?mm and =4?mm of thickness) and a minimum of 2?mm of buccal keratinized tissue
6. Presence of proper inter-arch space for implant prosthesis placement
7. No clinical evidence of active periodontal disease or oral infections

Exclusion Criteria

1. Systemic conditions that may interfere with the results (e.g., diabetes mellitus)
2. Local pathological defects
3. Unmotivated, uncooperative patients with poor oral hygiene
4. Habits that may jeopardize the implant longevity (e.g., smoking, alcoholism, or para-functional habits)
5. Bone-associated diseases or medication affecting bone metabolism (e.g., bisphosphonates)
6. History of radiation or chemotherapy
7. Inflammatory and autoimmune diseases
8. Shallow vestibular depth
9. History of oral surgery in the region of interest, which might have scared the periosteum

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flap advancement measured in mm using a UNC 15 periodontal probe. The flap was extended with minimum tension while the probe was positioned perpendicular to the crest of the ridge and kept parallel to the flap direction The readings should be taken at the mesial, middle, and distal parts of the flap, for each part the advancement measured three times and an average of the three readings is recorded by a single examiner.

Secondary Outcome Measures

Name	Time	Method
<br> Postoperative pain is recorded using the Numerical Rating scale (NRS) and postoperative swelling is recorded using the Visual Analogue Scale (VAS). Both scores are recorded for 7?days postoperatively and are collected from the patients on the suture removal visit.<br> Postoperative swelling is scored as follows:<br> 1. None (no swelling)<br> 2. Mild intraoral swelling confined to the surgical zone<br> 3. Moderate intraoral swelling confined to the surgical zone<br> 4. Intense (extraoral swelling spreading beyond the surgical zone)<br>