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How soft tissue augmentation after tooth extraction improves implant health: findings from a clinical trial

Impact of soft tissue augmentation on peri-implant health post-extraction: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18692174
Enrollment
30
Registered
2024-07-15
Start date
2023-08-23
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Pre-implant placement soft tissue augmentation Oral Health

Interventions

The method used for randomization was a closed envelope method. The envelopes were opened prior to the soft tissue augmentation procedure, allocating the patient into one of the three groups. Followi

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Had extraction sites that conformed to Type ST1 classification, as per Steigmann et al. (Steigmann et al., 2022), where both facial soft and hard tissues were preserved at levels consistent with the cementoenamel junction 2. Possessed at least 2 mm of keratinized tissue on the buccal aspect of the extraction site 3. Demonstrated commendable oral hygiene 4. Aged 18 years or above

Exclusion criteria

Exclusion criteria: 1. Exhibited buccal alveolar bone defects, such as dehiscence or fenestration, or experienced loss of the facial bone plate during extraction 2. Had systemic conditions that could impede bone healing 3. Were pregnant at the time of the study 4. Were classified as heavy smokers, defined as those consuming over 10 cigarettes daily

Design outcomes

Primary

MeasureTime frame
1. Pocket depth (PD) assessed using a periodontal probe gauged from the edge of the mucosa to the base of the pocket at two timepoints (baseline and 6 months after functional loading) at six distinct points around each implant, mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation. 2. Marginal bone level (MBL) evaluated at two key intervals: initially at the time of implant insertion (baseline) and subsequently after a period of 6 months. For each dental implant (DI), standardized periapical radiographs were captured at baseline and at the 6-month mark, employing a paralleling apparatus. The quantification of marginal bone loss (MBL) involved measuring the span from the inaugural point of bone contact with the implant to the crest of the implant. The assessment of bone loss incorporated both the mesial and distal dimensions of each DI.

Secondary

MeasureTime frame
1. Plaque Accumulation Index (PAI): adapted from the methodology proposed by Löe and colleagues (LÖE et al., 1972). this index was evaluated using a periodontal probe at six points around each implant: mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation at baseline and 6 months after functional loading. 2. Bleeding on Probing (BOP): a binary assessment indicating the presence or absence of bleeding, evaluated using a periodontal probe at six points around each implant: mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation at baseline and 6 months after functional loading. 3. Mucosal recession (MR): distance from the edge of the restoration to the gingival margin was evaluated using a periodontal probe at the mid-buccal surface at baseline and 6 months after functional loading.

Countries

Syria

Contacts

Public ContactAmmar Ibrahim
AmmarIbrahimISRCTN@gmail.com+963 (0)992964458

Outcome results

None listed

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