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

The modified cut-back incision technique to attain tension-free primary closure: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10220098
Enrollment
40
Registered
2023-05-05
Start date
2023-01-23
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partially edentulous patients requiring guided bone regeneration Oral Health

Interventions

Each participant will be assigned in ascending order at the enrolment visit. Patients will be randomly assigned in a 1:1 ratio to either the test group (mCAST) or the control group (classic periosteal

Sponsors

Instituto Superior de Ciências da Saúde Egas Moniz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. Postoperative swelling is scored as follows: 1. None (no swelling) 2. Mild intraoral swelling confined to the surgical zone 3. Moderate intraoral swelling confined to the surgical zone 4. Intense (extraoral swelling spreading beyond the surgical zone)

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026