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Treatment of gum recession around tooth implants

Coverage of buccal soft tissue dehiscences around implants with an acellular dermal matrix and apical buccal access. Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75484225
Enrollment
28
Registered
2021-07-20
Start date
2021-08-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Buccal soft tissue dehiscences (recessions) around dental implants Oral Health

Interventions

Surgical intervention: Control group: treatment of buccal soft tissue dehiscences with apical buccal access approach and autologous connective tissue graft. Test group: treatment of buccal soft tissue

Sponsors

Oral Reconstruction Foundation
Lead Sponsor
Arrow Development
Collaborator
ThinkingPerio Research
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Periodontally and systemically healthy 3. Full-mouth plaque score and full-mouth bleeding score = 20% (measured at four sites per tooth) 4. Correct implant 3-dimensional position or buccal position = 1 mm 5. Buccal soft tissue dehiscence =4 mm 6. Only osseointegrated implants 7. The patient must be able to perform good oral hygiene

Exclusion criteria

Exclusion criteria: 1. Contraindications for periodontal surgery 2. Patients pregnant or attempting to get pregnant 3. Malpositioned implant 4. Soft tissue dehiscence (STD) >4 mm 5. Existing of peri-implantitis 6. Severe bone loss (=4mm) 7. Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone >3 mm) 8. Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index >1) 9. Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior 10. Smoking more than 10 cigarettes a day

Design outcomes

Primary

MeasureTime frame
The primary outcome will be mean mid-facial recession coverage (mRC) measured as a percentage. Time frame: 6 months and 1 year with an intraoral scanning file (STL) and digital software

Secondary

MeasureTime frame
1. Esthetic score [ Time Frame: 6 months and 1 year ] measured using esthetic score measured using numeric values from 0 to 10 2. Patient-reported esthetics [ Time Frame: 6 months and 1 year ] measured using patient-reported esthetics measured using numeric values from 1 to 5 3. Patient-reported post-operative pain [ Time Frame: 2 weeks ] measured using patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10. 4. Keratinized tissue (KT) gain [ Time Frame: 6 months and 1 year ] measured using KT gain measured in mm with a manual periodontal probe 5. Keratinized tissue thickness (KTT) [ Time Frame: 6 months and 1 year ] measured using KTT gain measured in mm an intraoral scanning file (STL) and digital software 6. Professional-reported esthetics [ Time Frame: 6 months and 1 year ] measured using blinded examiner reported esthetics measured using numeric values from 1 to 5

Countries

Spain

Outcome results

None listed

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